Drug Master Files for: PROPRANOLOL HYDROCHLORIDE
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PROPRANOLOL HYDROCHLORIDE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
15849 | A | II | 2/1/2002 | IPCA LABORATORIES LTD | PROPRANOLOL HYDROCHLORIDE USP |
2265 | I | II | 4/25/1974 | AYERST LABORATORIES INC | DEXPROPRANOLOL INJ |
2968 | I | II | 6/24/1977 | ACIC LTD | PROPRANOLOL HCL USP XIX |
33222 | A | II | 10/30/2018 | LUPIN LTD | PROPRANOLOL HYDROCHLORIDE USP |
3565 | I | II | 7/6/1979 | INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPA | PROPRANOLOL HCL. |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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