Details for New Drug Application (NDA): 208014
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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 208014
Tradename: | FINGOLIMOD HYDROCHLORIDE |
Applicant: | Sun Pharm |
Ingredient: | fingolimod hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 208014
Mechanism of Action | Sphingosine 1-Phosphate Receptor Modulators |
Medical Subject Heading (MeSH) Categories for 208014
Suppliers and Packaging for NDA: 208014
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FINGOLIMOD HYDROCHLORIDE | fingolimod hydrochloride | CAPSULE;ORAL | 208014 | ANDA | Sun Pharmaceutical Industries, Inc. | 62756-064 | 62756-064-59 | 1 BLISTER PACK in 1 CARTON (62756-064-59) / 7 CAPSULE in 1 BLISTER PACK |
FINGOLIMOD HYDROCHLORIDE | fingolimod hydrochloride | CAPSULE;ORAL | 208014 | ANDA | Sun Pharmaceutical Industries, Inc. | 62756-064 | 62756-064-81 | 90 CAPSULE in 1 BOTTLE (62756-064-81) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 0.5MG BASE | ||||
Approval Date: | Dec 4, 2019 | TE: | AB | RLD: | No |
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