Details for New Drug Application (NDA): 207974
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NDA 207974 describes FINGOLIMOD HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Alembic, Alkem Labs Ltd, Apotex, Aurobindo Pharma Ltd, Biocon Ltd, Bionpharma, Chartwell Rx, Dr Reddys, Ezra Ventures, Glenmark Pharms Ltd, Hec Pharm Co Ltd, Hetero Labs Ltd V, Mylan, Prinston Inc, Sun Pharm, Teva Pharms Usa, and Zydus Pharms, and is included in nineteen NDAs. It is available from twenty suppliers. Additional details are available on the FINGOLIMOD HYDROCHLORIDE profile page.
The generic ingredient in FINGOLIMOD HYDROCHLORIDE is fingolimod hydrochloride. There are twenty-one drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the fingolimod hydrochloride profile page.
The generic ingredient in FINGOLIMOD HYDROCHLORIDE is fingolimod hydrochloride. There are twenty-one drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the fingolimod hydrochloride profile page.
Summary for 207974
| Tradename: | FINGOLIMOD HYDROCHLORIDE |
| Applicant: | Alembic |
| Ingredient: | fingolimod hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 207974
| Mechanism of Action | Sphingosine 1-Phosphate Receptor Modulators |
Medical Subject Heading (MeSH) Categories for 207974
Suppliers and Packaging for NDA: 207974
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FINGOLIMOD HYDROCHLORIDE | fingolimod hydrochloride | CAPSULE;ORAL | 207974 | ANDA | Alembic Pharmaceuticals Limited | 46708-228 | 46708-228-10 | 100 BLISTER PACK in 1 CARTON (46708-228-10) / 10 CAPSULE in 1 BLISTER PACK |
| FINGOLIMOD HYDROCHLORIDE | fingolimod hydrochloride | CAPSULE;ORAL | 207974 | ANDA | Alembic Pharmaceuticals Limited | 46708-228 | 46708-228-30 | 30 CAPSULE in 1 BOTTLE (46708-228-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 0.5MG BASE | ||||
| Approval Date: | Apr 24, 2026 | TE: | AB | RLD: | No | ||||
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