Drug Master Files for: valproic acid
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valproic acid Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 13161 | I | II | 8/26/1998 | SIEGFRIED CHEMICALS INC | VALPROIC ACID |
| 14607 | I | II | 11/5/1999 | SIEGFRIED CHEMICALS INC | VALPROIC ACID USP |
| 16558 | A | II | 4/28/2003 | SCI PHARMTECH INC | VALPROIC ACID |
| 17224 | A | II | 3/5/2004 | SIGNA SA DE CV | VALPROIC ACID USP |
| 20034 | A | II | 12/14/2006 | ANJAN DRUG PRIVATE LTD | VALPROIC ACID 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
