Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040881
Company: MIKART

• REMS

Products on ANDA 040881

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	300MG/15ML;10MG/15ML	SOLUTION;ORAL	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040881

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/25/2010	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
02/27/2024	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-16	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/04/2021	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/11/2019	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/21/2018	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-10	REMS - PROPOSAL - D-N-A		Label is not available on this site.
08/24/2018	SUPPL-9	Labeling-Container/Carton Labels		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.
12/16/2016	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/15/2016	SUPPL-6	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert		Label is not available on this site.
12/15/2016	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
10/18/2013	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
06/24/2011	SUPPL-2	Labeling-Package Insert		Label is not available on this site.