Drug Master Files for: metformin hydrochloride
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metformin hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11924 | I | II | 4/17/1996 | GROUPE LIPHA | METFORMIN HYDROCHLORIDE |
| 12647 | A | II | 9/8/1997 | USV PRIVATE LTD | METFORMIN HCL USP |
| 12670 | A | II | 9/30/1997 | MERCK SANTE SAS | METFORMIN HYDROCHLORIDE DRUG SUBTANCE |
| 13827 | I | II | 11/9/1998 | TAPI PUERTO RICO INC | METFORMIN HYDROCHLORIDE DRUG SUBSTANCE |
| 13869 | A | II | 11/24/1998 | FARMHISPANIA SA | METFORMIN HYDROCHLORIDE |
| 14055 | A | II | 3/19/1999 | WANBURY LTD | METFORMIN HYDROCHLORIDE |
| 14776 | A | II | 3/14/2000 | SHANGHAI MEDICINAL LTD | METFORMIN 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
