Details for New Drug Application (NDA): 208684
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The generic ingredient in EMFLAZA is deflazacort. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the deflazacort profile page.
Summary for 208684
Tradename: | EMFLAZA |
Applicant: | Ptc Therap |
Ingredient: | deflazacort |
Patents: | 0 |
Pharmacology for NDA: 208684
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 208684
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EMFLAZA | deflazacort | TABLET;ORAL | 208684 | NDA | PTC Therapeutics, Inc. | 52856-501 | 52856-501-01 | 100 TABLET in 1 BOTTLE (52856-501-01) |
EMFLAZA | deflazacort | TABLET;ORAL | 208684 | NDA | PTC Therapeutics, Inc. | 52856-502 | 52856-502-03 | 30 TABLET in 1 BOTTLE (52856-502-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 6MG | ||||
Approval Date: | Feb 9, 2017 | TE: | AB | RLD: | Yes | ||||
Regulatory Exclusivity Expiration: | Jun 7, 2026 | ||||||||
Regulatory Exclusivity Use: | TREATMENT OF DUCHENE MUSCULAR DYSTROPHY IN PATIENTS 2 YEARS OF AGE TO LESS THAN 5 YEARS OF AGE | ||||||||
Regulatory Exclusivity Expiration: | Feb 9, 2024 | ||||||||
Regulatory Exclusivity Use: | TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY IN PATIENTS 5 YEARS OF AGE AND OLDER |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 18MG | ||||
Approval Date: | Feb 9, 2017 | TE: | AB | RLD: | Yes | ||||
Regulatory Exclusivity Expiration: | Jun 7, 2026 | ||||||||
Regulatory Exclusivity Use: | TREATMENT OF DUCHENE MUSCULAR DYSTROPHY IN PATIENTS 2 YEARS OF AGE TO LESS THAN 5 YEARS OF AGE |
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