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 |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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