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Last Updated: December 14, 2024

Details for New Drug Application (NDA): 208653


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NDA 208653 describes APADAZ, which is a drug marketed by Zevra Therap and is included in one NDA. There are five patents protecting this drug. Additional details are available on the APADAZ profile page.

The generic ingredient in APADAZ is acetaminophen; benzhydrocodone hydrochloride. There are sixty-six drug master file entries for this compound. Additional details are available on the acetaminophen; benzhydrocodone hydrochloride profile page.
Summary for 208653
Tradename:APADAZ
Applicant:Zevra Therap
Ingredient:acetaminophen; benzhydrocodone hydrochloride
Patents:5
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208653
Generic Entry Date for 208653*:
Constraining patent/regulatory 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.

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength325MG;EQ 6.12MG BASE
Approval Date:Feb 23, 2018TE:RLD:Yes
Patent:8,461,137Patent Expiration:Feb 22, 2031Product Flag?YSubstance Flag?YDelist Request?
Patent:8,748,413Patent Expiration:Jul 1, 2030Product Flag?YSubstance Flag?YDelist Request?
Patent:8,828,978Patent Expiration:Jul 1, 2030Product Flag?YSubstance Flag?Delist Request?

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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.