Drug Master Files for: DIVALPROEX SODIUM
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DIVALPROEX SODIUM Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 14646 | A | II | 12/27/1999 | PCAS | DIVALPROEX SODIUM |
| 16224 | I | II | 11/5/2002 | CILAG AG | DIVALPROEX SODIUM |
| 16312 | A | II | 12/11/2002 | KATWIJK CHEMIE BV | DIVALPROEX SODIUM |
| 17349 | I | II | 5/3/2004 | PROCOS SPA | DIVALPROEX SODIUM |
| 17469 | A | II | 6/21/2004 | WOCKHARDT LTD | DIVALPROEX SODIUM |
| 18064 | I | II | 2/4/2005 | CHENG FONG CHEMICAL CO LTD | DIVALPROEX SODIUM |
| 18285 | A | II | 4/8/2005 | SCI PHARMTECH INC | DIVALPROEX SODIUM |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
