Details for New Drug Application (NDA): 208004
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NDA 208004 describes FINGOLIMOD HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, 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 eighteen NDAs. It is available from nineteen 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 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 suppliers are listed for this compound. Additional details are available on the fingolimod hydrochloride profile page.
Summary for 208004
| Tradename: | FINGOLIMOD HYDROCHLORIDE |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | fingolimod hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 208004
| Mechanism of Action | Sphingosine 1-Phosphate Receptor Modulators |
Medical Subject Heading (MeSH) Categories for 208004
Suppliers and Packaging for NDA: 208004
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FINGOLIMOD HYDROCHLORIDE | fingolimod hydrochloride | CAPSULE;ORAL | 208004 | ANDA | Ascend Laboratories, LLC | 67877-476 | 67877-476-30 | 30 CAPSULE in 1 BOTTLE (67877-476-30) |
| FINGOLIMOD HYDROCHLORIDE | fingolimod hydrochloride | CAPSULE;ORAL | 208004 | ANDA | Ascend Laboratories, LLC | 67877-476 | 67877-476-32 | 7 BLISTER PACK in 1 CARTON (67877-476-32) / 7 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 0.5MG BASE | ||||
| Approval Date: | Dec 30, 2020 | TE: | AB | RLD: | No | ||||
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