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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089736
Company: ABBVIE

Products on ANDA 089736

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VICODIN ES	ACETAMINOPHEN; HYDROCODONE BITARTRATE	750MG;7.5MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 089736

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/09/1988	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/089736.PDF

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/26/2006	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/089736s013lbl.pdf
04/02/2001	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
06/27/2000	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
03/16/2000	SUPPL-10	Manufacturing (CMC)-Facility		Label is not available on this site.
03/25/1999	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
09/28/1992	SUPPL-8	Labeling		Label is not available on this site.
07/17/1991	SUPPL-7	Labeling		Label is not available on this site.
07/17/1991	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
07/17/1991	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
07/17/1991	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
07/17/1991	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
07/17/1991	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/17/1991	SUPPL-1	Labeling		Label is not available on this site.

Labels for ANDA 089736

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/26/2006	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/089736s013lbl.pdf

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