Drug Master Files for: AUROBINDO PHARMA LTD
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AUROBINDO PHARMA LTD Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 16490 | A | II | 3/28/2003 | AUROBINDO PHARMA LTD | MIRTAZAPINE ANHYDROUS USP |
| 16850 | A | II | 9/19/2003 | AUROBINDO PHARMA LTD | CITALOPRAM HYDROBROMIDE USP |
| 16993 | A | II | 12/1/2003 | AUROBINDO PHARMA LTD | METFORMIN HYDROCHLORIDE USP |
| 17152 | A | II | 1/20/2004 | AUROBINDO PHARMA LTD | GLYBURIDE USP |
| 17217 | I | II | 3/5/2004 | AUROBINDO PHARMA LTD | AMIODARONE HYDROCHLORIDE |
| 17435 | A | II | 5/31/2004 | AUROBINDO PHARMA LTD | SERTRALINE HYDROCHLORIDE USP (CRYSTALLINE POLYMORPH FORM II) |
| 17562 | I | II | 7/5/2004 | AUROBINDO PHARMA LTD | 7-AMINO DESACETOXY CEPHALOSPORANIC ACID (7-ADCA) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
