Drug Master Files for: WOCKHARDT BIO AG
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WOCKHARDT BIO AG Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 16061 | I | II | 7/22/2002 | WOCKHARDT BIO AG | OXYBUTYNIN CHLORIDE USP |
| 17524 | A | II | 7/14/2004 | WOCKHARDT BIO AG | CLARITHROMYCIN USP |
| 26507 | A | II | 10/24/2012 | WOCKHARDT BIO AG | FESOTERODINE FUMARATE |
| 26743 | A | II | 2/26/2013 | WOCKHARDT BIO AG | ARIPIPRAZOLE |
| 27083 | A | II | 7/17/2013 | WOCKHARDT BIO AG | SAXAGLIPTIN HYDROCHLORIDE |
| 27084 | A | II | 5/27/2013 | WOCKHARDT BIO AG | SITAGLIPTIN PHOSPHATE |
| 28601 | A | II | 10/7/2014 | WOCKHARDT BIO AG | PALIPERIDONE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
