Drug Master Files for: nadolol
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nadolol Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
11192 | I | II | 11/12/1994 | SYNCHEM CHEMICALS PRIVATE LTD | NADOLOL |
24968 | A | II | 10/4/2011 | APICORE US LLC | NADOLOL, USP |
31735 | A | II | 6/1/2017 | BIOPHORE INDIA PHARMACEUTICALS PVT LTD | NADOLOL |
6247 | A | II | 4/4/1986 | FERMION OY | NADOLOL |
7426 | A | II | 4/11/1988 | SIGNA SA DE CV | NADOLOL USP |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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