Drug Master Files for: PROTRIPTYLINE HYDROCHLORIDE
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PROTRIPTYLINE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 20365 | A | II | 3/22/2007 | DIPHARMA FRANCIS SRL | PROTRIPTYLINE HYDROCHLORIDE |
| 21234 | I | II | 1/15/2008 | APICORE LLC | Protriptyline Hydrochloride |
| 23673 | A | II | 4/2/2010 | EMCURE PHARMACEUTICALS LTD | PROTRIPTYLINE HYDROCHLORIDE USP |
| 7896 | I | II | 1/28/1989 | WYCKOFF CHEMICAL CO INC | PROTRIPTYLINE HYDROCHLORIDE |
| 7994 | I | II | 3/13/1989 | DINAMITE DIPHARMA SPA | PROTRIPTYLINE HCl |
| 8381 | A | II | 11/23/1989 | OLON SPA | PROTRIPTYLINE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
