Drug Master Files for: PHENTERMINE HYDROCHLORIDE
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PHENTERMINE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 1214 | I | II | 8/1/1968 | TROPONWERKE GMBH CO KG | PHENTERMINE (C.A. NAME,-DIMETHYLPHENETHYLAMINE) |
| 15289 | A | II | 2/15/2001 | OLON SPA | PHENTERMINE HYDROCHLORIDE |
| 15442 | A | II | 5/14/2001 | CHEMISCHE FABRIK BERG GMBH | PHENTERMINE HYDROCHLORIDE USP |
| 15461 | I | II | 5/29/2001 | CAMBREX CHARLES CITY INC | PHENTERMINE HYDROCHLORIDE |
| 15940 | I | II | 4/17/2002 | CODY LABORATORIES INC A WHOLLY OWNED SUBSIDIARY OF LANNETT CO INC | PHENTERMINE HYDROCHLORIDE A INGREDIENT |
| 17039 | I | II | 12/17/2003 | PISGAH LABS INC | PHENTERMINE HYDROCHLORIDE, USP |
| 20135 | I | II | 1/11/2007 | CODY LABORATORIES INC A WHOLLY OWNED SUBSIDIARY OF LANNETT CO INC | PHENTERMINE RESIN - API |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
