Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040201
Company: MALLINCKRODT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 500MG;7.5MG TABLET;ORAL Discontinued None No No
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 500MG;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
02/27/1998 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40201ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/24/2011 SUPPL-29 Labeling

Label is not available on this site.

11/13/2002 SUPPL-11 Labeling

Label is not available on this site.

09/27/2002 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

08/05/2002 SUPPL-9 Labeling

Label is not available on this site.

08/05/2002 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/11/2002 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

04/25/2000 SUPPL-6 Labeling

Label is not available on this site.

04/25/2000 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/25/2000 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/25/2000 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/25/2000 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/25/2000 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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