Drug Master Files for: AZILSARTAN KAMEDOXOMIL
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AZILSARTAN KAMEDOXOMIL Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 28092 | A | II | 3/27/2014 | MSN LABORATORIES PRIVATE LTD | AZILSARTAN KAMEDOXOMIL [ROUTE CODE AK] |
| 28452 | A | II | 8/14/2014 | HEC PHARM CO LTD | AZILSARTAN KAMEDOXOMIL NON-STERILE BULK DRUG SUBSTANCE |
| 29488 | A | II | 6/30/2015 | ALEMBIC PHARMACEUTICALS LTD | AZILSARTAN MEDOXOMIL MONOPOTASSIUM |
| 29785 | A | II | 9/29/2015 | JUBILANT GENERICS LTD | AZILSARTAN MEDOXOMIL POTASSIUM |
| 29818 | A | II | 9/24/2015 | ALP PHARM BEIJING CO LTD | AZILSARTAN MEDOXOMIL |
| 31895 | A | II | 11/28/2017 | HONOUR LAB LTD | AZILSARTAN KAMEDOXOMIL |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
