Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040281
Company: VINTAGE PHARMS LLC

Products on ANDA 040281

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	500MG;5MG	TABLET;ORAL	Discontinued	None	No	No
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	750MG;7.5MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040281

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/30/1998	ORIG-1	Approval			Label Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40281_Hydrocodone%20Bitarttate%20and%20Acetaminophen_Prntlbl.pd https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40281ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040281_hydrocodone_toc.cfm

Labels for ANDA 040281

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/30/1998	ORIG-1	Approval			https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40281_Hydrocodone%20Bitarttate%20and%20Acetaminophen_Prntlbl.pd