Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040308
Company: BARR
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
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/2000/40308_Hydrocodone%20Bitartrate%20and%20Acetaminophen_Prntlbl. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40308ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/040308_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.

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/2000/40308_Hydrocodone%20Bitartrate%20and%20Acetaminophen_Prntlbl.

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