Drug Master Files for: NITROGLYCERIN
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NITROGLYCERIN Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10058 | A | II | 1/29/1993 | COPPERHEAD INVESTMENTS INC | SDM-71 NITROGLYCERIN TRANSDERMAL PATCH |
10066 | I | II | 2/1/1993 | ZENECA INC | SDM-70 NITROGLYCERIN/POLYMER MIXTURE |
10110 | A | II | 2/26/1993 | COPPERHEAD INVESTMENTS INC | SDM-74 (20/80 NITROGLYCERIN-SOLVATED ADHESIVE POLYMER) |
1040 | I | II | 3/7/1967 | ATLAS CHEMICAL INDUSTRIES INC | STANDARD DRUG MIXTURE NO. 16 (10% NITROGLYCERIN-LACTOSE MIXTURE) |
10874 | I | V | 4/13/1994 | PHARMACO LIFE SCIENCE RESEARCH | METHOD VALIDATION NITROGLYCERIN AND ITS DINITROGLYCERIN METABOLITES IN HUMAN PLASMA |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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