Drug Master Files for: moexipril hydrochloride
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moexipril hydrochloride Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10520 | I | II | 9/30/1993 | ORGAMOL SA | MOEXIPRIL HYDROCHLORIDE |
15172 | A | II | 12/6/2000 | ESTEVE QUIMICA SA | MOEXIPRIL HYDROCHLORIDE |
16670 | I | II | 6/25/2003 | UCB MANUFACTURING IRELAND LTD | MOEXIPRIL HYDROCHLORIDE |
17840 | A | II | 11/19/2004 | FARMHISPANIA SA | FH-109 (MOEXIPRIL HYDROCHLORIDE) |
19113 | A | II | 1/18/2006 | APOTEX PHARMACHEM INC | MOEXIPRIL HYDROCHLORIDE USP |
20426 | A | II | 4/9/2007 | GLENMARK PHARMACEUTICALS LTD | MOEXIPRIL HYDROCHLORIDE USP |
9942 | I | II | 11/6/1992 | PCAS | MOEXIPRIL 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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