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Dockets beginning in the year: 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 |
|
Year
2006 |
|
Docket No. |
Title of Docket |
Require Bioequivalence Studies for Generic
or Follow-on Formulations of MEGACE ES (megestrol acetate oral suspension
625 mg/5 ml) (New 10/18/06) | |
Permit an ANDA Suitability for Fexofenadine
Hydrochloride for Oral Suspension (Updated 3/7/07) | |
Revise the labeling requirements for
eggs sold in the United States (New 8/22/07)
| |
Health Claim Petition:
Barley Betafiber and Coronary Heart Disease (New
10/2/06) | |
Refrain from Approving any ANDA for
a Diazepam Rectal Gel that Relies on Diastat (New
6/4/07) | |
Declare that Clobetasol
Propionate from 0.05% is Suitable for Submission as an ANDA (New
12/6/06) | |
Food Allergen Labeling Petition (FALP):
Soy Lecithin When Used as Processing Aids (New
10/10/06) | |
To Urge the FDA's Prompt Action to Cancel
the GRAS Designation for Diacetyl Until Testing is Complete and the
Results are Independently Evaluated (Updated 8/27/07) | |
Immediately Add a Black Box Warning Regarding
the Risks of Tendinopathy and Tendon Rupture to the Product Labels of
all Fluoroquinolone Antibiotics Presently on the Market in the United
States (Updated
3/8/07)
| |
Revoke FDA's Prior Approval of Vagus
Nerve Stimulation (VNS) for Mangement of Treatment-resistant Depression
(TRD) (New
10/13/06) | |
ANDA Suitability for Alclometasone Dipropionate
Lotion, 0.05% (Updated
10/13/06) | |
Urge FDA to Take Regulatory Action to
Safeguard the Public from Violative Dental Devices Distributed by Five
Companies, Including Devices Manufactured in Unregistered Facilities
and/or Subject to Tampering (New
10/10/06) | |
Reformulation of Central Nervous System
(CNS) Stimulant Drugs (New 3/8/07) | |
Guidance for Industry and Food and Drug
Administration Staff; Draft Class II Special Controls Guidance Document:
Absorbable Hemostatic Device (Updated 7/24/07) | |
General and Plastic Surgery Devices;
Reclassification of the Absorbable Hemostatic Device (Updated
10/22/07) | |
Deny Request to switch ketotifen fumarate
ophthalmic solution, 0.025% (New
10/03/06) | |
Determine that the Discontinued Formulation
of Carbocaine Injection, 3% Supplied in 1.8 mL Cartridge was not Discontinued
for Safety and Efficacy Reasons (Updated
3/7/07) | |
Comments Relating to the
September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam (New
12/22/06) | |
Amend the Vancomycin HCl Package Insert
to Reflect Modifications of the Antimicrobial Susceptibility Interpretive
Criteria to Better Recognize Emerging Resistance Resulting in Compromised
Patient Outcomes (Updated 10/18/06) | |
Guidance for Industry, Clinical Laboratories,
and FDA Staff on In Vitro Diagnostic Multivariate Index Assays (Updated
8/6/07) | |
Ban Marketing of Estratest, Estratest
H.S. and Syntest D.S. and Syntest H.S. Associated with Menopause (New
9/19/06) | |
Guidance for Industry on Drug Interaction
Studies--Study Design, Data Analysis, and Implications for Dosing and
Labeling (New 3/13/07) | |
Medical Devices; Reprocessed Single-Use
Devices; Requirement for Submission of Validation Data (New
1/18/07) | |
Reclassification Petition fo Bone Heterografts
(Updated 11/1/07) | |
Guidance for Institutional Review Boards,
Clinical Investigators, and Sponsors; Exception from Informed Consent
Requirements for Emergency Research (Updated
11/13/06) | |
Regarding Review of Policies and Practices
of DDMAC and OCBQ to Ensure Compliance with First Amendment and Statutory
Mandate (New 8/17/06) | |
Request for Advisory Opinion Concerning
Orange Book Listing of Patents
(New 8/17/06) | |
Health Claim: Phytosterols and Reduced
Risk of Coronary Heart Disease (Updated
9/19/06) | |
Removal
of Labeling for Medisense Precision Advanced Diabetes Management System
(Updated 10/13/06) | |
Investigate and Take Regulatory Action
to Protect Surgical Patients from a Potential Significant Safety risk
in Connection with Propofol Injectable Emulsion Marketed by Bedford
Laboratories (New 8/25/06) | |
Compel the Agency to Follow Requirements
of the Drug Listing Act of 1972 (New
8/25/06) | |
ANDA for ELOXATIN (oxaliplatin for injection)
lLyophilized Powder for Infusion, 50 mg and 100 mg Vials (New
8/25/06) | |
To amend 21CFR 201.17 Regarding Expiration
Dates (New 8/24/06) | |
Publish Specific Requirements for Applications
Seeking Approval to Market Ttherapeutically Equivalent Versions of Insulin
and Human Growth Hormone (Updated
3 /20/07 ) | |
Permit the Filing of an ANDA Suitability
for Loperamide Hydrochloride Orally Dissolving Strips, 2 mg (Updated
10/11/06) | |
Permit the Filing of an ANDA Suitability
for Sodium Chloride Injection (New
8/22/06) | |
ANDA Suitability for Glycoprrolate Tablets,
USP 1.5 mg (New 8/22/06) | |
Determine whether Eloxatin (Oxaliplatin
for Injection) 50 mg and 100 mg Sterile Lyophilized Powder Vials (NDA
#21-492 has been Withdrawn for Safety or Effectiveness Reasons (New
8/22/06) | |
To permit an ANDA Suitability for Eloxatin
(Oxaliplatin for injection) (New
8/14/06) | |
International Conference
on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical
Procedures and/or Acceptance Criteria
(Updated 11/22/06) | |
International Conference
on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical
Procedures and/or Acceptance Criteria; Annex on Residue on Ignition/Sulphated
Ash General Chapter (Updated
11/21/06) | |
Unique Device Identification
(New 12/13/06) | |
Determine whether Eloxatin (Oxaliplatin)
has been voluntarily withdrawn or withheld from sale for safety or efficacy
reasons (New 8/14/06) | |
Risk Management Program for Fentanyl
Products (New 8/7/06) | |
Permit an ANDA Suitability for Alprazolam
(New 8/11/06) | |
Determine Whether Phoslo (calcium acetate)
Tablets, eq 169 mg Calcium, have been Voluntarily Withdrawn from Sale
for Safety or Efficacy Reasons (New
8/11/06) | |
Food Allergen Labeling
(FALN): Lyophilized Probiotic Cultures
(Updated 8/11/06) | |
Determine Whether Phoslo (calcium acetate)
Capsules eq169 mg calcium have been Voluntarily Withdrawn from Sale
for Safety or Effcacy Reasons (New
8/9/06) | |
Refrain from Granting any Bioequivalence
Waiver for any ANDA Referencing Duramed's NDA 21-544 for Seasonale (New
8/9/06) | |
Patent Extension Application for Phakic
Intraocular Lenses, U.S. Patent No. 5,192,319 (New
10/27/06) | |
Determination of Orudis KT (ketoprofen,
12.5 mg) Oral Tablet (New
8/1/06) | |
Agency Information Collection Activities;
Proposed Collection; Comment Request; FDA Survey of Physicians Perceptions
of the Impact of Early Risk Communication about Medical Products (New
8/22/06) | |
Emergency Request to Open Blood Products
Advisory Committee Meeting on Friday, July 14, 2006 (New
8/1/06) | |
Agency Information Collection Activities:
Proposed Collection; Comment Request; Bar Code Label Requirement for
Human Drug and Biological Products (Updated
8/8/06) | |
Agency Information Collection Activities;
Proposed Collection; Comment Request; Guidance for Industry on Continuous
Marketing Applications: Pilot 2 - Scientific Feedback and Interactions
During Development of Fast Track Products Under the Prescription Drug
User Fee Act (New 8/9/06) | |
Agency Information Collection Activities;
Proposed Collection; Comment Request; Food Labeling; Notification Procedures
for Statements on Dietary Supplements (New
8/9/06) | |
Agency Information Collection Activities;
Proposed Collection; Comment Request; Establishing and Maintaining a
List of U.S. Dairy Product Manufacturers/Processors With Interest in
Exporting to Chile (Updated
1/12/07) | |
ANDA for Water for Injection, USP, in
3-, 5-, 15-, and 30-mL Volumes (Updated
9/19/06) | |
ANDA Suitability for 0.9% Sodium Chloride
Injection (New 7/31/06)
| |
Amend practice of
assessing the performance of medical devices for determining in vitro
susceptibility of bacteria or fungi to included CLSl (Updated
3/20/07) | |
ANDA Suitability
for Dextroamphetamine Sulfate Tablets
(New 7/27/06) | |
To permit an ANDA
Suitability for Cefdinir (New 07/25/06) | |
Permit an ANADA suitability
for Neomycin (Updated 10/13/06) | |
Patent Extension Application for EXJADE
(deferasirox), U.S. Patent No. 6,465,504 (New 2/23/07)
| |
Immediately
approve ANDA No. 77-837 upon the June 23, 2006 patent expiration of
U.S. Patent No. 4,444,784 (New 07/25/06) | |
Food and Drug Administration to Make
a Determination that the Discontinued Formulation of Warner Chilcott's
Duricel (cefadroxil) tablets 1 g was not Discontinued for Safety and
Efficacy Reasons (Updated 4/19/07) | |
ANDA Suitability
for Loperamide Hydrochloride
(New 7/25/06) | |
Label Change or Removal from the Market
of the Psychotropic Drug Depakote (Updated
10/11/06) | |
Refrain from Approving all Abbreviated
Applications for Generic Enrofloxacin that Purport to Copy Bayer's Baytril
100 Injectable Solution
(Updated 12/20/06) | |
Manufactured Food Regulatory Program
Standards (Updated 9/10/07) | |
Exclusivity Determination
for Risperidone (Updated 2/9/07) | |
Qualified Health
Claim (QHC) : Corn Oil and corn Oil Containing Foods and Heart Disease
(Updated 7/27/06) | |
Approval of any Budesonide Inhalation
Suspension Product using Pulmicort Respules (Updated
1/22/07) | |
Appeal District Court Civil Action No.
05-1838 (RWR) and Deny the Citzen Petitions of Ivax and Ranbaxy (Updated
7/28/06) | |
Food Allergen Labeling Petition (FALP):
Culture Media with Enzyme-Treated Soy Solids (New
6/20/06) | |
Over-the-Counter
Drug Products; Safety and Efficacy Review; Additional Laxative Ingredient
(New 7/27/06) | |
Over-the-Counter Drug Products; Safety
and Efficacy Review; Additional Sunscreen Ingredient (New
8/22/06) | |
Abbrevation New Drug Application Suitability
for Lidocaine Hydrochloride (New 7/14/06) | |
Prescription Drug Marketing Act Pedigree
Requirements under 21 CFR Part 203; Effective Date and Compliance Policy
Guide (Updated 1/19/07) | |
Take Appropriate Remedial Action Against
the Apparent Misbranding of Generic Azithromycin Marketed by Pliva,
Inc. (Updated 7/28/06) | |
Switch Plan B and Equivalent EC Drugs
from Precription-only to OTC Status Without Age Restrictions, Exempt
from Prescription-dispensing Requirement any new Drug Eligible for Filing
an ANDA Because of its Equivalence to Plan B (Updated
10/23/06) | |
Agency Information Collection Activities;
Proposed Collection; Comment Request; Administrative Detention and Banned
Medical Devices (Updated 6/21/06) | |
To Permit an Abbrevation New Drug Application
Triamcinolone Diacetate Suspension (New 7/07/06) | |
Amend Regulations for Products Composed
of Engineered Nanoparticles Generally and Sunscreen Drug Products Composed
of Engineered Nanoparticles sSpecifically (Updated
3/8/07) | |
Safety or Efficacy of Diastat (diazepam
rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml (Updated
8/24/06) | |
Permit the Filing of an ANDA for Loratadine
Soft Gelatin Capsules 10 mg (Updated 6/21/06) | |
ANDA Suitability for Cetirizine Hydrochloride
Soft Gelatin Capsules 5 mg and 10 mg (Updated
7/6/06) | |
Require Vitamin D be Added to Cereal-grain
Products (Updated 8/22/06) | |
Cefotan (cefotetan injection), Equivalent
1 g base/vial and 2 g base/vial, Manufactured by AstraZeneca has been
Voluntarily Withdrawn from Sale for Safety and Efficacy Reasons (New
6/30/06) | |
ANDA for Lithium Carbonate Tablets, 300
mg (NDA 016834) (Updated 8/30/06) | |
Determine that Wyeth Pharmaceuticals,
Inc. Discontinued its Original Formulation of Zosyn (piperacillin and
tazobactam) for Reasons Unrelated to Safety and Efficacy and to Allow
Companies to File Abbreviated New Drug Applications Seeking Approval
to Market Zosyn Formulation (Updated 8/11/06) | |
Guidance for Industry and Food and Drug
Administration; Guidance for the Use of Bayesian Statistics in Medical
Device Clinical Trials (Updated 10/03/06) | |
Guidance for Industry and Food and Drug
Administration Staff; Class II Special Controls Guidance Document: Olfactory
Test Device; Availabilit (Updated 6/21/06) | |
Agency Information Collection
Activities: Survey of Healthcare Professionals on the Food Safety and
Nutrition Information That They Provide to Pregnant Women (New
10/05/06) | |
Withdraw New Drug
Application NDA 21-179 FOR Renagel Tablets (Severlamer Hydrochloride)
400 AND 800 MG (Updated 11/21/06) | |
Agency Information Collection Activities;
Proposed Collection; Comment Request; Guidance on Reagents for Detection
of Specific Novel Influenza A Viruses (New
8/9/06) | |
Product Stability Data: Notice of Pilot
Project (New 8/4/06) | |
Immediately Ban Fluoroquinolone Antibiotic
Gatifloxacin in Humans (Updated 11/21/06) | |
ANDA Suitability for Methotrexate (Updated
6/30/06) | |
FDA to Determine that any Drug is Therapeutically
Equivalent or AB-rated to BiDil (Isosorbide Dinitrate and Hydralazine
Hydrochloride) (New 6/30/06) | |
Request Approval of any Abbreviated
New Drug Application Relying on Zosyn (piperacillin and tazobactam for
injection) as its Reference Product be Contingent upon the Proposed
Product (Updated 8/11/06) | |
Food Labeling: Reference Daily Intakes
& Daily Reference Values (New 2/13/08) | |
ANDA Suitability for Oxycodone and Acetaminophen
Drug Product in an Orally Disintigrating Form (New
6/28/06) | |
Initiate Administrative Proceedings for
the Purpose of Investigating and Enjoining the Unlawful Sale and Distribution
by International Tan Makers, Inc., of Ultraviolet Suntanning Lamps that
are Misbranded as Defined by 21 U.S.C. 352(a); and to Impose Appropriate
Remedies Against, and to Require Corrective Actions by International
Tan Makers, Inc. (New 6/27/06) | |
Request ANDA Suitability of Dichlorphenamide
Tablets USP, 50 mg (New 6/27/06) | |
Revoke Regulations that Provided for
the Inclusion and Addition of Sucralose as a Non-nutritive Sweetener
in Food (New 6/27/06) | |
Remove from the Market, the Prescription
Version of Xenical (Orlistat, Roche Pharmaceuticals) (Updated
02/08/07) | |
Stay the Current Approvable Letter with
Conditions of Any and All Premarket Applications for Silicone Gel-filled
Breast Implants (Updated 8/8/06) | |
Determine whether Risperdal M Tab (Risperidone)
Orally Disintegrating Tablets, 3 mg and 4 mg (NDA No. 21-444), was Voluntarily
Withdrawn or Withheld from Sale for Safety or Efficacy Reasons (Updated
07/28/06) | |
Amend Reg. for Prescription Drug Advertising
to Establish Separate Criteria for Practitioner-Directed & Consumer-Directed
Advertising and Establish Advisory Committee (Updated
8/03/06) | |
ANDA Suitability for Gemcitabine (New
6/19/06) | |
Delalutin Hydroxyprogesterone Caproate)
Injection was not Withdrawn for Safety or Effectiveness Reasons and
Therefore Suitable for ANDA (Updated 7/18/06) | |
Laser Light Show (New
6/9/06) | |
Laser Light Show (New
6/9/06) | |
To withhold Approval of any ANDA for
a Generic Version of Acitretin Capsules (New 5/1/06) | |
Nutrient Content Claims: EPA and DHA
Omega-3 Fatty Acids (Updated 6/22/06) | |
Issue Guidance to Industry Outlining
Procedures and Standards for Initiating an "Expanded Access Program"
for Unapproved Drugs (Updated 9/19/06)
| |
ANDA suitability for Epirubicin Hydrochloride
(Updated 5/22/06) | |
Take specific actions with regard to
the animal product that is manufactured by S&M NuTec LLC known as
a "Greenie" (Updated 8/8/06) | |
Determine whether Dexedrine (dextroamphetamine
sulfate) Oral Solution 5 mg/ 5 mL has been voluntarily withdrawn from
sale for safety or efficacy reasons (New 4/20/06) | |
Stay any approvals of an Abbreviated
New Drug Application (ANDA) for Vancocin Capsules (Updated
4/2/07) | |
Request all applicants for fentanyl transdermal
systems conduct a study to support the safety of their fentanyl transdermal
products (Updated 8/23/07) | |
ANDA Suitability for Cetirizine Hydrochloride
Orally Disintegrating Tablets, 5 mg and 10 mg (New
4/17/06) | |
Enforce ban on carbon monoxide in the
packaging of fresh tuna and fresh tuna that is subsequently frozen (New
4/17/06) | |
Food Allergen Labeling Notification (FLN):
Anyhydrous Lactitol and Lactitol Monohydrate (New
3/20/06) | |
Laser Light Show (New
5/15/06) | |
Agency Information Collection Activities;
Announcement of Office of Management and Budget Approval; Guidance for
Reagents for Detection of Specific Novel Influenza A Viruses (New
5/31/06) | |
ANDA Suitability for Omeprazole Tablets,
20 mg (proposed formulation) (New 4/17/06) | |
Refrain from taking administrative action
regarding approval and/or effective date of final approval of any and
all ANDAs for a generic version of Metrogel-Vaginal 0.75% (Updated
10/18/06) | |
Projector for a Laser Light Show (New
5/15/06) | |
Laser Display Device (New
5/15/06) | |
Guidance for Industry:
Informed Consent Recommendations for Source Plasma Donors Participating
in Plasmapheresis and Immunization Programs (Updated
8/10/06) | |
FDA-Regulated Products
Containing Nanotechnology Materials (Updated 12/19/06) | |
New Animal Drugs; Adamantane and Neuraminidase
Inhibitor Anti-influenza Drugs; Extralabel Animal Drug Use; Order of
Prohibition (New 5/10/06)
| |
Agency Information Collection Activities:
Proposed Collection; Comment Request; Environmental Impact Considerations
Part 25 (21 CFR Part 25) (New 6/13/06) | |
Agency Information Collection Activities:
Proposed Collection; Comment Request; Requirements for Submission of
Labeling for Human Prescription Drugs and Biologics in Electronic Format
(New 6/13/06) | |
Take Appropriate Remedial Action Relating
to an Apparent Safety Issue rRegarding Bellatal ER (New
10/13/06) | |
Petition for Review of Codex Standard
for Honey Under 21 CFR 130.6 (Updated 10/13/06) | |
Medical Devices; Immunology and Microbiology
Devices; Classification of Reagents for Detection of Specific Novel
Influenza A Viruses (New
5/22/06)
| |
Class II Special Controls Guidance Document:
Reagents for Detection of Specific Novel Influenza A Viruses (New
5/22/06) | |
Define the term natural before a natural
claim can be made on foods and beverages regulated by the FDA (Updated
3/22/07) | |
ECOAnimal Health Seeks Permission to
File an ANADA for a Generic Equivalent of the Innovator Product Ivomec
(ivermectin) Injection for Cattle and Swine, 1% Sterile Solution NADA
128-409, Merial LTD. (Updated 8/22/06) | |
Determine that Astra Zeneca's Diprivan,Teva
Sicor's Propofol Injectable Emulsion, and Bedford Laboratories Propofol
Injectable Emulsion are misbranded (New
9/19/06) | |
Qualified Health Claim (QHC): Unsaturated
Fatty Acids from Canola Oil and Reduced Risk of Coronary Heart Disease
(Updated 10/17/06) | |
Immediately begin the phased removal
from the market of propoxyphene (Darvon) and all propoxyphene-containing
product (Updated 10/06/06) | |
Stay Approval of all Supplements to
Biologics Licenses Issued to Genentech (BLA# 103705 ) and Biogen (BLA#
103737) for Rituxan (Rituximab) (Updated 10/03/06) | |
Guidance for Industry; Clinical Data
Needed to Support the Licensure of Pandemic Influenza Vaccines (Updated
7/17/06) | |
To declare that the drug product, Butalbital,
50 mg and acetaminophen, 300 mg Tablets, is suitable for consideration
in an abbreviated new drug application (ANDA) (New
9/19/06) | |
To Exempt the Class II device Cranial
Orthoses from Premarket Notification Requirements under section 510(m)(2)
(Updated 2/23/07) | |
Draft Guidance for Industry on Clinical
Data Needed to Support the Licensure of Trivalent Inactivated Influenza
Vaccines (Updated 5/17/06) | |
Agency Information Collection Activities:
Proposed Collection; Comment Request; Prescription Drug Marketing Act
of 1987; 21 CFR Part 203 (Updated 7/18/06) | |
Refrain from Lifting the Administrative
Stay for Amlodipine Maleate Tablets (NDA 21-435) Until After September
25, 2007 (New 9/1/06) | |
ANDA for Prednisolone Sodium Phosphate,
USP, Oral Solution, 10 mg Prednisolone Base/5mL (New
6/19/06) | |
513 (e) Reclassification
of Tissue Adhesive For Soft Tissue Approximation (Updated
9/26/06) | |
Misbranding of Generic Azithromycin
Products Marketed by Teva Pharmaceuticals USA and Sandoz Inc.(Updated
8/25/06) | |
Health Claim Petition: Soluble Fiber
from Certain Foods and Coronary Heart Disease (Updated
6/30/06) | |
Determine whether Syntocinon (oxytocin)
Nasal Spray NDA 12-285, has been Voluntarily Withdrawn for Safety or
Effectiveness Reasons (Updated 8/1/06) | |
Index of Legally Marketed Unapproved
New Animal Drugs for Minor Species (New 02/13/2007)
| |
Guidance for Industry
and FDA Staff: Whole Grains Label Statements (Updated
7/14/06) | |
Emerging Clostridial Disease; Public
Workshop (Updated 06/21/06) | |
Draft Guidance for Industry and Food
and Drug Administration; The Review and Inspection of Premarket Approval
Applications under the Bioresearch Monitoring Program; Availability
(New 10/18/06) | |
Expanded Access to Investigational Drugs
for Treatment Use (Updated 7/10/07) | |
ANADA for Unibute Granules 200 mg Phenylbutazone
per g of Granules Instant of Paste (Updated 6/22/06) | |
Determine whether Sustiva (efavirenz)
Tablets, 300 mg (NDA 21-360), has been Voluntarily Withdrawn for Safety
or Effectiveness Reasons (New
08/22/06) | |
Blood Vessels Recovered
with Organs and Intended for Use in Organ Transplantation (New
10/02/06) | |
Reduce the Public Health Risks Associated
with the Use of Drugs Manufactured or Processed at Foreign Facilities
(New 8/14/06) | |
Refrain from Approval any ANDA for Celestone
Soluspan (Updated 7/28/06) | |
Patent Extension Application for Onyx
Liquid Embolic System (LES), U.S. Patent No. 5,667,767 (New
2/13/06) | |
Genetic Toxicology Testing: the Ames
Assay, Mouse Lymphoma Assay and the Micronucleus Assay (Updated
45/24/07) | |
Patent Extension Application for TYGACIL
(tigecycline), U.S. Patent No. 5,529,990 (New
2/13/06) | |
Patent Extension Application for CUBICIN
(daptomycin for injection), U.S. Patent No. 4,885,24 (New
2/13/06) | |
Genetic Toxicology Testing: the Ames
Assay, Mouse Lymphoma Assay and the Micronucleus Assay (New
2/14/06) | |
To Issue a Regulation that would Efficaciously
Inform the General Public about the Quantitaive Caffeine Content of
the Foods they Consume (New 2/13/06) | |
Orthopedic Devices; Reclassification
of the Intervertebral Body Fusion Device (New
6/15/06) | |
Human Subject Protection--Information
for Institutional Review Boards, Clinical Investigators, and Sponsors;
Rescission, Reissuance, and Development of FDA Guidance Documents (Updated
6/20/06) | |
Food Allergen Labeling Notification for
Purity Foods Vita Spelt (Updated 6/20/06) | |
Projector for a Laser Light Show (New
2/13/06) | |
Guidance for Industry and FDA Staff;
Pharmacogenetic Tests and Genetic Tests for Heritable Markers (New
7/3/06) | |
Patent Extension Application for DRAXXIN
(tulathromycin), U.S. Patent No. 6,420,536 (New
2/13/06) | |
Oxycodone Hydrochloride and Acetaminophen
Oral Solution, 10 mg / 300 mg/5 mL. (Updated 5/10/06) | |
Patent Extension Application for Lyrica
(pregabalin), U.S. Patent No. 6,197,819 (New 2/13/06) | |
Patent Extension Application for Lyrica
(pregabalin), U.S. Patent No. 6,001,876 (New 2/13/06) | |
Patent Extension Application for CYMBALTA
(duloxetine hydrochloride), U.S. Patent No. 5,023,269
(New 2/13/06) | |
Patent Extension Application for BiDIL
(combination of hydralazine hydrochloride and isosorbide dinitrate),
U.S. Patent No. 4,868,179 (New 2/13/06) | |
FDA to declare that Methocarbamol Tablets
USP, 1000 mg is suitable for submission as an ANDA (New
2/13/06) | |
Date of Approval for Lunesta (Eszopiclone)
Tablets (Updated 8/1/06) |
Page updated January 15, 2009 kk
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