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OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN

ANDA

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | A203573 | PH HEALTH LTD

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Lachman Consultant Services, Inc. - Citizen Petition FDA-2009-P-0203 · 5 docket documents Lachman Consultant Services, Inc., filed this citizen petition on behalf of an unnamed client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Oxycodone Hydrochloride and Acetaminophen Effervescent Tablets in strengths of 2.5 mg/500 mg, 5 m	Other	2009-05-01	Withdrawn	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 23, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 325MG/5ML;5MG/5ML

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Dec 18, 2014

No patent or exclusivity listings for this strength.