Drug Master Files for: LEVOTHYROXINE SODIUM
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LEVOTHYROXINE SODIUM Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 14256 | I | II | 6/29/1999 | RHODIA INDUSTRIE CHIMIQUE MULHOUSE DORNACH | LEVOTHYROXINE SODIUM USP |
| 14715 | A | II | 2/1/2000 | PEPTIDO GMBH | LEVOTHYROXINE SODIUM |
| 24402 | A | II | 10/20/2011 | EXCELLA GMBH AND CO KG | LEVOTHYROXINE SODIUM |
| 25818 | I | II | 2/20/2012 | APOTEX PHARMACHEM INDIA PVT LTD | LEVOTHYROXINE SODIUM USP |
| 29098 | A | II | 3/14/2015 | AZICO BIOPHORE INDIA PVT LTD | LEVOTHYROXINE SODIUM |
| 29550 | A | II | 7/27/2015 | GLAND PHARMA LTD | LEVOTHYROXINE SODIUM 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
