Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040099
Company: APIL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
06/25/1997 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
03/04/2021 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

10/07/2019 SUPPL-23 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/040099s023lbl.pdf
09/20/2018 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-21 REMS - PROPOSAL - D-N-A

Label is not available on this site.

12/16/2016 SUPPL-20 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/16/2016 SUPPL-19 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

11/20/2014 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040099Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040099Orig1s018ltr.pdf
10/18/2013 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

07/06/2011 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

08/15/2003 SUPPL-9 Labeling

Label is not available on this site.

07/27/2001 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

02/15/2000 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

07/13/1999 SUPPL-6 Labeling

Label is not available on this site.

07/13/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/13/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/13/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/13/1999 SUPPL-2 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/040099_S.PDF
02/06/1998 SUPPL-1 Labeling

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-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/040099s023lbl.pdf
11/20/2014 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040099Orig1s018lbl.pdf

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