Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040834
Company: PHARM ASSOC

• Other Important Information from FDA

• REMS

Products on ANDA 040834

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG/15ML;10MG/15ML	SOLUTION;ORAL	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040834

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/18/2008	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-22	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-21	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
10/11/2019	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
09/21/2018	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-12	REMS - PROPOSAL - D-N-A		Label is not available on this site.
12/16/2016	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/18/2013	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
06/24/2011	SUPPL-5	Labeling-Package Insert		Label is not available on this site.