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ANDA

ACETAMINOPHEN; HYDROCODONE BITARTRATE | A040148 | ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD

5 strengths0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Lachman Consultant Services, Inc. - Citizen Petition FDA-2011-P-0302 · 4 docket documents Lachman Consultant Services, Inc. filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Hydrocodone Bitartrate and Acetaminophen Effervescent Tablets in strengths of 2.5 mg/325 mg, 5 mg/325 mg, 7.5 mg/325 mg, and 10 mg/325	Other	2011-05-25	Denied	—

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 22, 2015	SUPPL -53	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

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#002 — 500MG;10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 14, 1997

#001 — 325MG;10MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 14, 1997

No patent or exclusivity listings for this strength.

#003 — 325MG;7.5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 12, 2000

#004 — 325MG;2.5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 7, 2014

#005 — 325MG;5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 7, 2014