Drug Master Files for: Lupin Ltd
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Lupin Ltd Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11291 | A | II | 1/9/1995 | LUPIN LTD | RIFAMYCIN-S (BULK SUBSTANCE) |
| 12086 | A | II | 8/2/1996 | LUPIN LTD | 7-ACCA |
| 13214 | A | II | 4/30/1998 | LUPIN LTD | RIFAMPIN USP |
| 13217 | I | II | 4/30/1998 | LUPIN LTD | CEFACLOR USP AS MAUFACTURED IN MANDIDEEP, INDIA |
| 13219 | A | II | 4/30/1998 | LUPIN LTD | STERILE CEFOTAXIME SODIUM USP |
| 14769 | A | II | 3/9/2000 | LUPIN LTD | CEFUROXIME AXETIL (CRYSTALLINE) USP |
| 15098 | A | II | 10/18/2000 | LUPIN LTD | LISINOPRIL USP |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
