Drug Master Files for: acetaminophen
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acetaminophen Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
11436 | I | II | 4/5/1995 | GRANULES INDIA LTD | COMPRESSO-90-P (ACETAMINOPHEN GRANULES 90%) |
11513 | I | II | 5/11/1995 | GRANULES INDIA LTD | COMPRESSO-90-CP(F) (ACETAMINOPHEN GRANULES 90%) |
12025 | I | II | 7/3/1996 | WATSON LABORATORIES INC | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, 10 MG\650 MG |
12366 | I | II | 2/5/1997 | MATERIALS PROCESSING TECHNOLOGY INC | DIRECTLY COMPRESSIBLE ACETAMINOPHEN DC-90B |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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