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Dockets Management

Dockets Entered On October 2, 2006
Docket # Title
1976N-0052N OTC Nasal Decongestants
1981N-0022 OTC Weight Control Drug Products for Human Use
2001D-0475 Providing Regulatory Submissions in Electronic Format-ANDA's
2003D-0364 Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Annual Reports for NDAs and ANDAs
2004P-0157 ANDA Suitability for Amoxicillin and Clavulanate Potassium Tablets for Oral Suspension 200 mg/28.5 mg and 400 mg/57 mg
2006D-0275 Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems
2006N-0107 FDA-Regulated Products Containing Nanotechnology Materials
2006N-0283 Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Survey of Physicians Perceptions of the Impact of Early Risk Communication about Medical Products
2006N-0352 Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
2006P-0151 Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
2006P-0209 Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
2006P-0402 FDA would not regulate as Medical Device Assays Developed by Clinical Laboratories strictly for in-house use (home brew)
2006V-0401 Laser Display Device
1976N-0052N OTC Nasal Decongestants
SUP 10 Robinson & Cole, LLP Vol #: 105
1981N-0022 OTC Weight Control Drug Products for Human Use
SUP 9 Robinson & Cole, LLP Vol #: 116
2001D-0475 Providing Regulatory Submissions in Electronic Format-ANDA's
NWL 1 FDA Vol #: 1
2003D-0364 Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Annual Reports for NDAs and ANDAs
NWL 1 FDA Vol #: 1
2004P-0157 ANDA Suitability for Amoxicillin and Clavulanate Potassium Tablets for Oral Suspension 200 mg/28.5 mg and 400 mg/57 mg
PAV 1 FDA/CDER to The Weinberg Group Inc. Vol #: 2
2006D-0275 Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems
EC 1 Mrs. Alpha Anderson Vol #: 1
2006N-0107 FDA-Regulated Products Containing Nanotechnology Materials
C 9 A. Rhodes Vol #: 1
2006N-0283 Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Survey of Physicians Perceptions of the Impact of Early Risk Communication about Medical Products
C 3 Pfizer, Inc. Vol #: 1
2006N-0352 Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
EC 66 Mrs. Nancy Hokkanen Vol #: 3
EC 67 Mrs. Priscilla Lorentzen Vol #: 3
EC 68 Mrs. Debra Kaiser Vol #: 3
2006P-0151 Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
AMD 1 Chemically Associated Neurological Disorders Vol #: 1
EC 727 Mrs. Pamela Morrell Vol #: 3
2006P-0209 Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
RC 1 Lachman Consultant Services, Inc. Vol #: 1
2006P-0402 FDA would not regulate as Medical Device Assays Developed by Clinical Laboratories strictly for in-house use (home brew)
ACK 1 FDA/DDM to Washington Legal Foundation (WLF) Vol #: 1
CP 1 Washington Legal Foundation (WLF) Vol #: 1
2006V-0401 Laser Display Device
ACK 1 FDA / DDM to Superimaging Inc and AP Marketing Development Vol #: 1
ACK 2 Number not used Vol #: 1
VAR 1 Superimaging Inc and AP Marketing Development Vol #: 1

Page created on October 6, 2006 kk

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