Drug Master Files for: Asta
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Asta Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
13128 | I | V | 8/12/1998 | ASTA MEDICA INC | TOXICOLOGY INFORMATION FOR PERIFOSINE (D-21266) |
15262 | A | II | 2/5/2001 | AMPHASTAR FRANCE PHARMACEUTICALS SAS | RECOMBINANT HUMAN INSULIN |
16426 | I | III | 2/14/2003 | AMPHASTAR PHARMACEUTICALS INC | PROCESSING FOR WASHING, DEPYROGENAING, SILICONIZING, STERILIZING AND PACKAGING OF STERILE STOPPERS |
16587 | I | II | 5/14/2003 | MASTAFA NEVZAT ILAC SANAYII | SULBACTAM SODIUM (NON-STERILE) |
26059 | A | II | 5/25/2012 | AMPHASTAR NANJING PHARMACEUTICALS INC | SEMI-PURIFIED HEPARIN SODIUM |
27837 | A | II | 3/6/2014 | AMPHASTAR NANJING PHARMACEUTICALS INC | BECLOMETHASONE DIPROPIONATE |
29454 | A | II | 6/29/2015 | AMPHASTAR NANJING PHARMACEUTICALS INC | FLUTICASONE PROPIONATE, 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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