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ANDA

ACETAMINOPHEN; HYDROCODONE BITARTRATE | A040148 | ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD

5 strengths0 unique patents0 unique exclusivities

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