Drug Master Files for: leuprolide acetate
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leuprolide acetate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10416 | A | II | 8/13/1993 | TAKEDA PHARMACEUTICAL CO LTD | LEUPROLIDE ACETATE |
| 11236 | A | II | 12/8/1994 | BACHEM AMERICAS INC | LEUPROLIDE ACETATE |
| 12052 | I | II | 7/18/1996 | SPECGX LLC | LEUPROLIDE ACETATE |
| 13150 | A | II | 8/21/1998 | POLYPEPTIDE LABORATORIES INC | LEUPROLIDE |
| 13822 | A | II | 11/6/1998 | BACHEM AG | LEUPROLIDE ACETATE |
| 13922 | I | II | 12/29/1998 | PENINSULA LABS INC | LEUPROLIDE |
| 14440 | I | II | 10/8/1999 | GENZYME CORP | LEUPROLIDE ACETATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
