Drug Master Files for: Mikart
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Mikart Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
4913 | I | II | 3/31/1983 | MIKART INC | ATLANTA, GA. PLANT ON MARIETTA BLVD. |
6089 | I | II | 11/13/1985 | MIKART INC | ACETAMINOPHEN & CODEINE PHOSPHATE TABS. 650/60 |
6207 | I | II | 2/21/1986 | MIKART INC | ACETAMINOPHEN AND HYDROCODONE BITARTRATE |
6467 | I | II | 7/11/1986 | MIKART INC | LORTAB TABLETS |
6486 | I | II | 7/17/1986 | MIKART INC | LORTAB 7 TABLETS |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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