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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. 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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