Drug Master Files for: nortriptyline
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nortriptyline Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 21330 | A | II | 1/31/2008 | TEVA PHARMACEUTICAL INDUSTRIES LTD | NORTRIPTYLINE HYDROCHLORIDE USP |
| 25380 | A | II | 10/7/2011 | CENTAUR PHARMACEUTICALS PVT LTD | NORTRIPTYLINE HCI USP |
| 2890 | I | II | 3/18/1977 | LILLY RESEARCH LABORATORIES DIV ELI LILLY AND CO | NORTRIPTYLINE HCL CAPSULES |
| 2891 | I | II | 3/18/1977 | LILLY RESEARCH LABORATORIES DIV ELI LILLY AND CO | NORTRIPTYLINE HCL SOLUTION |
| 31974 | A | II | 9/8/2017 | VASUDHA PHARMA CHEM LTD | NORTRIPTYLINE HYDROCHLORIDE USP |
| 3291 | I | II | 9/15/1978 | SIFAVITOR SRL | NORTRIPTYLINE HCL, USP |
| 33227 | A | II | 9/29/2018 | RL FINE CHEM PVT LTD | NORTRIPTYLINE HYDROCHLORIDE |
| >DMF No. | >Status | >Type | >Submission Date | >Holder | >Subject |
Drug Master File Glossary
STATUS OF DMFS
- A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
- I = Inactive
- N = Not an assigned number
- P = DMF Pending Filing Review
TYPES OF DMFs
- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
- Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
- Type III Packaging Material
- Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
- Type V FDA Accepted Reference Information
