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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040099
Company: APIL

Medication Guide

Products on ANDA 040099

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040099

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-Medication Guide, Labeling-Package Insert		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.

Labels for ANDA 040099

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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