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. 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.
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: | 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.
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 | Zevra Therapeutics, Inc. | 70040-0145 | 70040-0145-1 | 100 TABLET in 1 BOTTLE, PLASTIC (70040-0145-1) |
| APADAZ | acetaminophen; benzhydrocodone hydrochloride | TABLET;ORAL | 208653 | NDA | Zevra Therapeutics, Inc. | 70040-0167 | 70040-0167-1 | 100 TABLET in 1 BOTTLE, PLASTIC (70040-0167-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 325MG;EQ 6.12MG BASE | ||||
| Approval Date: | Feb 23, 2018 | TE: | RLD: | Yes | |||||
| Patent: | 8,461,137 | Patent Expiration: | Feb 22, 2031 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | 8,748,413 | Patent Expiration: | Jul 1, 2030 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | 8,828,978 | Patent Expiration: | Jul 1, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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