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About FDA
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FDA Forms
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| Form | Date | Food and Drugs Administration Forms | Format | Contact Info |
|---|---|---|---|---|
| 0356h | 10/2005 | {FDA has OMB approval to use the form until 6/30/2010} Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use | (PDF - 264KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 1571 | 04/2006 | Investigational New Drug Application (IND) [Instructions] | (HTM - 0KB) |
CDER Drug Info 301-796-3400 |
| 1571 | 04/2006 | {FDA has OMB approval to use the form until 8/31/2011}. Investigational New Drug Application | (PDF - 221KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 1572 | 05/2006 | {FDA has OMB approval to use the form until 8/31/2011}. Statement of Investigator | (PDF - 208KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2252 | 06/2008 | Transmittal of Annual Report for Drugs and Biologics for Human Use | (PDF - 339KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2253 | 06/2008 | Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use | (PDF - 351KB) |
DDMAC 301-796-1200 |
| 2626 | 07/2004 | New Drug Application/Biologic Licensing Application (Blue Folder) Archival | (HTML - 14KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2626a | 07/2004 | New Drug Application/Biologic Licensing Application (Red Folder) Chemistry | (HTML - 14KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2626b | 07/2004 | New Drug Application/Biologic Licensing Application (Yellow Folder) Pharmacology | (HTML - 14KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2626c | 07/2004 | New Drug Application/Biologic Licensing Application (Orange Folder) Pharmacokinetic | (HTML - 14KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2626d | 07/2004 | New Drug Application/Biologic Licensing Application (White Folder) Microbiology | (HTML - 14KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2626e | 07/2004 | New Drug Application/Biologic Licensing Application (Tan Folder) Clinical Data | (HTML - 14KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2626f | 07/2004 | New Drug Application/Biologic Licensing Application (Light Green Folder) Statistics | (HTML - 14KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2626h | 07/2004 | New Drug Application/Biologic Licensing Application (Maroon Folder) Field Submission Chemistry | (HTML - 14KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2657 | 06/2009 | Drug Product Listing (HTML) | (HTM - 0KB) | eDRLS@fda.hhs.gov |
| 2658 | 06/2009 | Registered Establishments Report of Private Label Distributors (HTML) | (HTM - 0KB) | eDRLS@fda.hhs.gov |
| 2675 | 08/1990 | Investigational New Drug Folder (Red) | (HTML - 14KB) | CDER Drug Info at 301-796-3400 |
| 2675a | 10/1986 | Investigational New Drug Folder (Green) | (HTML - 14KB) | CDER Drug Info at 301-796-3400 |
| 2675b | 10/1986 | Investigational New Drug Folder (Orange) | (HTML - 14KB) | CDER Drug Info at 301-796-3400 |
| 2914 | 08/2008 | Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drugs Membership Summary | (PDF - 429KB) |
RDRC 301-796-2050 |
| 2915 | 08/2008 | Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drugs Study Summary | (PDF - 856KB) |
RDRC 301-796-2050 |
| 3316 | 08/1985 | DRUG MASTER FILE REVIEW BINDER-Red | (HTML - 14KB) | CDER Drug Info at 301-796-3400 |
| 3316a | 08/1985 | DRUG MASTER FILE ARCHIVAL BINDER-Blue | (HTML - 14KB) | CDER Drug Info at 301-796-3400 |
| 3331 | 01/2009 | NDA Field Alert Report | (PDF - 425KB) |
Juliaette Johnson 301-827-8928 |
| 3397 | 01/2007 | User Fee Cover Sheet | (HTM - 0KB) |
Mike Jones 301-443-5151 |
| 3437 | 06/1996 | CDER Pediatric Use Supplement | (PDF - 36KB) |
CDR 301-827-4210 |
| 3454 | 04/2006 | Certification: Financial Interest and Arrangements of Clinical Investigator | (PDF - 47KB) |
Leah W. Ripper 301-796-1282 |
| 3455 | 04/2006 | Disclosure: Financial Interest and Arrangements of Clinical Investigators | (PDF - 56KB) |
Leah W. Ripper 301-796-1282 |
| 3542 | 12/2008 | Patent Information Submitted Upon and After Approval of An NDA or Supplemen | (PDF - 420KB) |
Mary Ann Holovac, R.Ph. 240-276-8971 |
| 3542a | 12/2008 | Patent Information Submitted With the Filing of An NDA, Amendment, or Supp | (PDF - 417KB) |
Mary Ann Holovac 301-827-5846 |
| 3613b | 06/2006 | Supplementary Information Certificate of a Pharmaceutical Product | (PDF - 328KB) |
Import/Export Team CBER 301-827-6201 or CDER 301-827-8940 or CDRH 301-796-7400 or CVM 240-276-0132 |
| 3625 | 10/2008 | DSI Complaint Record | (PDF - 378KB) |
Joseph Salewski 301-796-3395 |
| 3664 | 07/2007 | My Medicine Record | (PDF - 331KB) |
Cindi Fitzpatrick 301-796-3115 |
| 3671 | 02/2009 | Common EMEA/FDA Application for Orphan Medicinal Product Designation | (PDF - 554KB) |
Kathy Needleman 301-827-3666 |
| 3674 | 11/2008 | Certification of Compliance, under 42 U.S.C. , 282(j)(5)(B), with Requireme | (PDF - 411KB) |
Jarilyn Dupont 301-796-4716 |
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