Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040288
Company: VINTAGE PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZYDONE ACETAMINOPHEN; HYDROCODONE BITARTRATE 400MG;5MG TABLET;ORAL Discontinued None No No
ZYDONE ACETAMINOPHEN; HYDROCODONE BITARTRATE 400MG;7.5MG TABLET;ORAL Discontinued None No No
ZYDONE ACETAMINOPHEN; HYDROCODONE BITARTRATE 400MG;10MG TABLET;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/27/1998 ORIG-1 Approval Letter (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40288ltr.pdf

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