Drug Master Files for: hydrocodone bitartrate
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hydrocodone bitartrate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 12025 | I | II | 7/3/1996 | WATSON LABORATORIES INC | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, 10 MG\650 MG |
| 12029 | I | II | 7/3/1996 | WATSON LABORATORIES INC | HYDROCODONE BITARTRATE TABLETS, 10 MG |
| 12848 | A | II | 2/5/1998 | JOHNSON MATTHEY PHARMACEUTICAL MATERIALS | HYDROCODONE BITARTRATE, USP |
| 16102 | I | II | 8/19/2002 | MALLINCKRODT INC | HYDROCODONE ALKALOID |
| 17285 | A | II | 3/25/2004 | SPECGX LLC | HYDROCODONE POLISTIREX |
| 19460 | A | II | 5/26/2006 | SIEGFRIED USA LLC | HYDROCODONE BITARTRATE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
