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Last Updated: January 25, 2021

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Details for New Drug Application (NDA): 208685

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NDA 208685 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.
Summary for 208685
Tradename:EMFLAZA
Applicant:Ptc Therap
Ingredient:deflazacort
Patents:0
Generic Entry Opportunity Date for 208685
Generic Entry Date for 208685*:
Constraining patent/regulatory exclusivity:
FDA exclusivity
Dosage:
SUSPENSION;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: 208685
Suppliers and Packaging for NDA: 208685
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EMFLAZA deflazacort SUSPENSION;ORAL 208685 NDA PTC Therapeutics, Inc. 52856-505 52856-505-21 13 mL in 1 BOTTLE (52856-505-21)
EMFLAZA deflazacort SUSPENSION;ORAL 208685 NDA PTC Therapeutics, Inc. 52856-505 52856-505-22 13 mL in 1 BOTTLE (52856-505-22)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength22.75MG/ML
Approval Date:Feb 9, 2017TE: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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.