Drug Master Files for: aztreonam
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aztreonam Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 16751 | I | II | 8/8/2003 | TEVA PHARMACEUTICAL INDUSTRIES LTD | AZTREONAM |
| 17184 | A | II | 2/23/2004 | EUTICALS SPA | AZTREONAM INTERMEDIATE NON-STERILE ALPHA-FORM |
| 19342 | A | II | 4/11/2006 | TEVA PHARMACEUTICAL INDUSTRIES LTD | AZTREONAM USP |
| 20014 | I | II | 12/5/2006 | ORCHID CHEMICALS AND PHARMACEUTICALS LTD | AZTREONAM |
| 20907 | I | II | 9/7/2007 | CHANGZHOU FANGYUAN PHARMACEUTICAL CO LTD | AZTREONAM, NON-STERILE BULK DRUG SUBSTANCE |
| 23971 | I | II | 7/6/2010 | CHONGQING FUAN PHARMACEUTICAL CO LTD | AZTREONAM USP (NON-STERILE BULK DRUG SUBSTANCE) |
| 26856 | A | II | 10/18/2013 | CHONGQING SHENGHUAXI PHARMACEUTICAL CO LTD | AZTREONAM |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
