Drug Master Files for: fingolimod hydrochloride
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fingolimod hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 26401 | A | II | 11/5/2012 | DR REDDYS LABORATORIES LTD | FINGOLIMOD HYDROCHLORIDE |
| 26807 | A | II | 2/20/2013 | GLENMARK PHARMACEUTICALS LTD | FINGOLIMOD HYDROCHLORIDE |
| 27730 | A | II | 12/17/2013 | MYLAN LABORATORIES LTD | FINGOLIMOD HYDROCHLORIDE USP |
| 27830 | A | II | 12/30/2013 | MSN LABORATORIES PRIVATE LTD | FINGOLIMOD HYDROCHLORIDE [ROUTE CODE FH] |
| 27983 | A | II | 3/28/2014 | APOTEX PHARMACHEM INDIA PVT LTD | FINGOLIMOD HYDROCHLORIDE |
| 28057 | A | II | 3/28/2014 | ALEMBIC PHARMACEUTICALS LTD | FINGOLIMOD HYDROCHLORIDE |
| 28142 | A | II | 4/23/2014 | TAI HENG INDUSTRY CO LTD | FINGOLIMOD HYDROCHLORIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
