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TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

ANDA

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE | A076475 | CHARTWELL RX SCIENCES LLC

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-0429 · 6 docket documents Lachman Consultant Services, Inc. filed this petition under Section 505(b)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Tramadol Hydrochloride and Acetaminophen Tablets, 75 mg/650 mg suitable for consideration in an abbreviated new drug application (ANDA), based o	Other	2009-09-13	Withdrawn	—

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 28, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 325MG;37.5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 21, 2005

No patent or exclusivity listings for this strength.