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| FDA Form # | Date | Title | Format | Paper Copy or Contact Info. |
|---|---|---|---|---|
| 356h | 04/03 | Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use | |
Pamela Pope 301-827-9540 |
| 1571 | 01/03 | Investigational New Drug Application {Instructions} | |
Mia Prather Mia.Prather@fda.hhs.gov |
| 1572 | 01/03 | Statement of Investigator {Instructions} | |
Mia Prather Mia.Prather@fda.hhs.gov |
| 2252 | 04/02 | Transmittal of Annual Report for Drugs for Human Use | |
Mia Prather Mia.Prather@fda.hhs.gov |
| 2253 | 07/02 | Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use | |
Mike Wade 301-827-2828 |
| 2567 | 09/02 | Transmittal of Labels and Circulars | |
Pamela Pope 301-827-9540 |
| 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 | 09/03 | Registration of Drug Establishment/Labeler Code Assignment {Instructions} THIS FORM MUST BE SUBMITTED IN TRIPLICATE | |
OTCOM 301-827-4573 |
| 2657 | 08/04 | Drug Product Listing {Instructions} | |
OTCOM 301-827-4573 |
| 2658 | 08/04 | Registered Establishments Report of Private Label Distributors {Instructions} |
|
OTCOM 301-827-4573 |
| 2675 | 07/84 | Investigational New Drug Folder (Red) | Not Yet Electronic | GPO |
| 2675a | 07/84 | Investigational New Drug Folder (Green) | Not Yet Electronic | GPO |
| 2675b | 07/84 | Investigational New Drug Folder (Orange) | Not Yet Electronic | GPO |
| 2914 | 10/01 | Radioactive Drug Research Committee (RDRC) Report/Research Use of Drug Membership Summary | |
Ray Farkas & Richard Fekla
301-827-7482 |
| 2915 | 10/01 | Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drug Study Summary | |
PPF |
| 3316 | 08/85 | Folder, Drug Master File (Red) | Not Yet Electronic | GPO |
| 3316a | 08/85 | Folder, Drug Master File (Blue) | Not Yet Electronic | GPO |
| 3331 | 02/03 | NDA Field Alert Report | |
Juliaette Johnson 301-827-8930 |
| 3397 | 12/03 | User Fee Cover Sheet | |
Mike Jones 301-594-2041 |
| 3437 | 06/95 | CDER Pediatric Use Supplement | |
CDR 301-827-4210 |
| 3454 | 02/03 | Certification: Financial Interest and Arrangements of Clinical Investigators | |
Leah W. Ripper 301-827-5921 |
| 3455 | 02/03 | Disclosure: Financial Interest and Arrangements of Clinical Investigators | |
Leah W. Ripper 301-827-5921 |
| 3500 | 09/03 | MedWatch: FDA Medical Product Reporting Program {Instructions} | |
MEDWATCH 1-800-FDA-1088 |
| 3500A | 09/03 | MedWatch: FDA Medical Products Reporting Program - Mandatory {Instructions} |
|
MEDWATCH 1-800-FDA-1088 |
| 3542 | 07/03 | Patent Information Submitted Upon and After Approval of An NDA or Supplement | |
Mary Ann Holovac 301-827-5846 |
| 3542a | 07/03 | Patent Information Submitted With the Filing of An NDA, Amendment, or Supplement | |
Mary Ann Holovac 301-827-5846 |
| 3543 | 12/03 | Certificate of a Pharmaceutical Product | |
Jocelyn V. Lewis 301-827-8983 |
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Edition: September 30, 2004
