Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040309
Company: BARR

Products on ANDA 040309

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	500MG;10MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040309

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/26/2000	ORIG-1	Approval			Label Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40309_Hydrocodone%20Bitartrate%20and%20Acetaminophen_Prntlbl. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40309ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/040309_hydrocodone-bitartrate_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/23/2001	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for ANDA 040309

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/26/2000	ORIG-1	Approval			https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40309_Hydrocodone%20Bitartrate%20and%20Acetaminophen_Prntlbl.