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Last Updated: October 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208653

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NDA 208653 describes APADAZ, which is a drug marketed by Kvk Tech Inc and is included in one NDA. It is available from one supplier. 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. One supplier is listed for this compound. Additional details are available on the acetaminophen; benzhydrocodone hydrochloride profile page.
Summary for 208653
Tradename:APADAZ
Applicant:Kvk Tech Inc
Ingredient:acetaminophen; benzhydrocodone hydrochloride
Patents:5
Generic Entry Opportunity 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.

Suppliers and Packaging for NDA: 208653
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
APADAZ acetaminophen; benzhydrocodone hydrochloride TABLET;ORAL 208653 NDA KVK-Tech, Inc. 10702-340 10702-340-01 100 TABLET in 1 BOTTLE, PLASTIC (10702-340-01)
APADAZ acetaminophen; benzhydrocodone hydrochloride TABLET;ORAL 208653 NDA KVK-Tech, Inc. 10702-341 10702-341-01 100 TABLET in 1 BOTTLE, PLASTIC (10702-341-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;EQ 6.12MG BASE
Approval Date:Feb 23, 2018TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Feb 22, 2031Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Jul 1, 2030Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Jul 1, 2030Product Flag?YSubstance Flag?Delist Request?

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