Details for New Drug Application (NDA): 208684
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NDA 208684 describes EMFLAZA, which is a drug marketed by Ptc Therap and is included in two NDAs. It is available from one supplier. Additional details are available on the EMFLAZA profile page.
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.
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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