Drug Master Files for: LABETALOL HYDROCHLORIDE
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LABETALOL HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10901 | I | II | 5/18/1994 | TEVA PHARMACEUTICAL INDUSTRIES LTD | LABETALOL HYDROCHLORIDE |
| 10918 | A | II | 6/8/1994 | PROCOS SPA | LABETALOL HCl |
| 11779 | A | II | 12/22/1995 | OLON SPA | LABETALOL HYDROCHLORIDE |
| 12758 | A | II | 11/24/1997 | CAMBREX PROFARMACO MILANO SRL | LABETALOL HYDROCHLORIDE |
| 14702 | A | II | 2/4/2000 | COSMA SPA | LABETALOL HYDROCHLORIDE |
| 16314 | A | II | 12/17/2002 | TEVA PHARMACEUTICAL INDUSTRIES LTD | LABETALOL HYDROCHLORIDE |
| 17319 | I | II | 4/13/2004 | UNION QUIMICO FARMACEUTICA SA (UQUIFA SA) | LABETALOL 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
