Drug Master Files for: diltiazem hydrochloride
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diltiazem hydrochloride Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10381 | I | II | 7/9/1993 | MITSUBISHI TANABE PHARMA CORP | DILTIAZEM HYDROCHLORIDE (PROCESS C) |
10466 | I | II | 6/2/1993 | SUMITRA PHARMACEUTICALS AND CHEMICALS LTD | DILTIAZEM HYDROCHLORIDE |
11077 | I | II | 9/9/1994 | TANABE SEIYAKU CO LTD | DILTIAZEM MALATE |
11161 | I | II | 10/24/1994 | MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC | DILTIAZEM ER TABLETS |
11170 | I | II | 10/28/1994 | MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC | ENALAPRIL MALEATE & DILTIAZEM ER TABLETS |
11504 | I | II | 5/11/1995 | DR REDDYS LABORATORIES LTD | DILTIAZEM HYDROCHLORIDE |
12071 | I | II | 8/2/1996 | ORION CORP FERMION | DILTIAZEM HCL PROCESS II |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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