Drug Master Files for: LORAZEPAM
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LORAZEPAM Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
15156 | I | II | 11/21/2000 | SUN PHARMACEUTICAL INDUSTRIES LTD | LORAZEPAM USP |
17765 | A | II | 10/20/2004 | CIPLA LTD | LORAZEPAM USP |
19006 | A | II | 11/28/2005 | RL FINE CHEM PVT LTD | LORAZEPAM |
19268 | I | II | 3/21/2006 | TEVA PHARMACEUTICAL INDUSTRIES LTD | LORAZEPAM |
22460 | A | II | 1/23/2009 | CENTAUR PHARMACEUTICALS PVT LTD | LORAZEPAM 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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