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| FDA Form # | Date | Title | Format | Paper Copy or Contact Info. |
|---|---|---|---|---|
| 356h | 10/05 | Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use | |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 1571 | 04/06 | Investigational New Drug Application {Instructions} |
|
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 1572 | 05/06 | Statement of Investigator {Instructions-CDER} | |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2252 | 06/08 | Transmittal of Annual Report for Drugs and Biologics for Human Use | |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2253 | 06/08 | Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use | |
DDMAC 301-796-1200 |
| 2567 | 10/02 | Transmittal of Labels and Circulars | |
CBER MATT 301-827-2000 |
| 2626 | 07/04 | New Drug Application/Biologic Licensing Application (Blue Folder) Archival | Not Yet Electronic | GPO |
| 2626a | 07/04 | New Drug Application/Biologic Licensing Application (Red Folder) Chemistry | Not Yet Electronic | GPO |
| 2626b | 07/04 | New Drug Application/Biologic Licensing Application (Yellow Folder) Pharmacology | Not Yet Electronic | GPO |
| 2626c | 07/04 | New Drug Application/Biologic Licensing Application (Orange Folder) Pharmacokinetic | Not Yet Electronic | GPO |
| 2626d | 07/04 | New Drug Application/Biologic Licensing Application (White Folder) Microbiology | Not Yet Electronic | GPO |
| 2626e | 07/04 | New Drug Application/Biologic Licensing Application (Tan Folder) Clinical Data | Not Yet Electronic | GPO |
| 2626f | 07/04 | New Drug Application/Biologic Licensing Application (Light Green Folder) Statistics | Not Yet Electronic | GPO |
| 2626h | 07/04 | New Drug Application/Biologic Licensing Application (Maroon Folder) Field Submission Chemistry | Not Yet Electronic | GPO |
| 2656 | 08/07 | Registration of Drug Establishment/Labeler Code Assignment {Instructions} THIS FORM MUST BE SUBMITTED IN TRIPLICATE | |
DRLS drls@fda.hhs.gov or 301-210-2840 |
| 2657 | 02/08 | Drug Product Listing {Instructions} | |
DRLS drls@fda.hhs.gov or 301-210-2840 |
| 2658 | 08/07 | Registered Establishments Report of Private Label Distributors {Instructions} |
|
DRLS drls@fda.hhs.gov or 301-210-2840 |
| 2675 | 8/90 | Investigational New Drug Folder (Red) | Not Yet Electronic | GPO |
| 2675a | 10/86 | Investigational New Drug Folder (Green) | Not Yet Electronic | GPO |
| 2675b | 10/86 | Investigational New Drug Folder (Orange) | Not Yet Electronic | GPO |
| 2914 | 08/08 | Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drugs Membership Summary | |
RDRC 301-796-2050 |
| 2915 | 08/086 | Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drugs Study Summary | |
RDRC 301-796-2050 |
| 3316 | 08/85 | Red - DRUG MASTER FILE REVIEW BINDER | Not Yet Electronic | GPO |
| 3316a | 08/85 | Blue - DRUG MASTER FILE ARCHIVAL BINDER | Not Yet Electronic | GPO |
| 3331 | 04/06 | NDA Field Alert Report | |
Juliaette
Johnson 301-827-8928 |
| 3397 | 01/07 | User Fee Cover Sheet | |
Mike Jones 301-443-5151 |
| 3437 | 06/95 | CDER Pediatric Use Supplement | |
CDR 301-827-4210 |
| 3454 | 04/06 | Certification: Financial Interest and Arrangements of Clinical Investigators | |
Leah W. Ripper 301-796-1282 |
| 3455 | 04/06 | Disclosure: Financial Interest and Arrangements of Clinical Investigators | |
Leah W. Ripper 301-796-1282 |
| 3500 | 02/06 | MedWatch: The FDA Safety Information and Adverse Event Reporting Program {Instructions} |
|
MEDWATCH 1-800-FDA-1088 |
| 3500A | 02/06 | MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory {Instructions} |
|
MEDWATCH 1-800-FDA-1088 |
| 3542 | 07/07 | Patent Information Submitted Upon and After Approval of An NDA or Supplement |
|
Mary Ann Holovac 240-276-8971 |
| 3542a | 07/07 | Patent Information Submitted With the Filing of An NDA, Amendment, or Supplement | |
Mary Ann Holovac 240-276-8971 |
| 3613b | 06/06 | Supplementary Information Certificate of a Pharmaceutical Product | |
Import/Export Team CBER 301-827-6201 or CDER 301-827-8940 |
| 3664 | 07/07 | My Medicine Record {Instructions} | |
Cindi Fitzpatrick 301-796-3115 |
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Edition: December 16, 2008