Drug Master Files for: levodopa
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levodopa Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
12379 | A | II | 2/19/1997 | AJINOMOTO CO INC | LEVODOPA |
12505 | I | II | 5/15/1997 | EGIS PHARMACEUTICALS PRIVATE LTD | LEVODOPA USP BULK |
1367 | I | II | 5/7/1969 | LILLY RESEARCH LABORATORIES DIV ELI LILLY AND CO | LEVODOPA (COMPOUND 7550) |
1649 | I | II | 2/1/1971 | GD SEARLE AND CO | L-DOPA (OR LEVODOPA) IN BULK ONLY |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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