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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. One supplier is 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. One supplier is 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 |
Generic Entry Opportunity Date for 208684
Generic Entry Date for 208684*:
Constraining patent/regulatory exclusivity:
FDA exclusivity Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 9, 2022 | ||||||||
| Regulatory Exclusivity Use: | |||||||||
| Regulatory Exclusivity Expiration: | Feb 9, 2024 | ||||||||
| Regulatory Exclusivity Use: | |||||||||
| Regulatory Exclusivity Expiration: | Jun 7, 2026 | ||||||||
| Regulatory Exclusivity Use: | |||||||||
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