Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040148
Company: APIL
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
NORCO ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET;ORAL Discontinued None No No
NORCO ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Discontinued None No No
NORCO ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;2.5MG TABLET;ORAL Discontinued None No No
NORCO ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;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
02/14/1997 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/22/2021 SUPPL-75 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

10/07/2019 SUPPL-73 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/040148s073lbl.pdf
09/20/2018 SUPPL-72 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-71 REMS - PROPOSAL - D-N-A

Label is not available on this site.

02/06/2017 SUPPL-68 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/16/2016 SUPPL-67 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/16/2016 SUPPL-62 Labeling-Package Insert

Label is not available on this site.

12/15/2016 SUPPL-60 Labeling-Package Insert

Label is not available on this site.

12/19/2014 SUPPL-53 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040148s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040148s053ltr.pdf
04/07/2017 SUPPL-51 Labeling-Container/Carton Labels

Label is not available on this site.

10/18/2013 SUPPL-50 Labeling-Package Insert

Label is not available on this site.

07/01/2011 SUPPL-46 Labeling-Package Insert

Label is not available on this site.

01/09/2008 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

07/30/2003 SUPPL-15 Labeling

Label is not available on this site.

07/30/2003 SUPPL-14 Labeling

Label is not available on this site.

05/21/2002 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

05/11/2000 SUPPL-12 Labeling

Label is not available on this site.

09/12/2000 SUPPL-11 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/040148s.pdf
10/29/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/12/2000 SUPPL-5 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/040148s.pdf
09/12/2000 SUPPL-4 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/040148s.pdf
09/12/2000 SUPPL-3 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/040148s.pdf
09/12/2000 SUPPL-2 Manufacturing (CMC)-New Strength Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/040148s.pdf
10/07/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/07/2019 SUPPL-73 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/040148s073lbl.pdf
12/19/2014 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040148s053lbl.pdf

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