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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040846
Company: MIKART

Products on ANDA 040846

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;2.5MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040846

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/09/2010	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
03/05/2021	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
10/28/2019	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/21/2018	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-11	REMS - PROPOSAL - D-N-A		Label is not available on this site.
08/24/2018	SUPPL-10	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
12/16/2016	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-8	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/15/2016	SUPPL-6	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
10/18/2013	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/040432s006,40556s012,40658s006, 40846s005, 89699s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/040432s006,040556s012,040658s006,040846s005,089699s044ltr.pdf
05/12/2014	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
06/24/2011	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
08/25/2010	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 040846

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/18/2013	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/040432s006,40556s012,40658s006, 40846s005, 89699s044lbl.pdf

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