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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040838
Company: PHARM ASSOC

REMS

Products on ANDA 040838

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG/15ML;7.5MG/15ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040838

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/10/2013	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
12/22/2025	SUPPL-24	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/31/2024	SUPPL-23	REMS - MODIFIED - D-N-A		Label is not available on this site.
02/27/2024	SUPPL-22	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/15/2023	SUPPL-20	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/04/2021	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
10/11/2019	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
09/21/2018	SUPPL-13	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.
12/16/2016	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/16/2016	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
12/15/2016	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
10/18/2013	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 040838

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

SOLUTION;ORAL; 325MG/15ML;7.5MG/15ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG/15ML;7.5MG/15ML	SOLUTION;ORAL	Prescription	No	AA	040894	GENUS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG/15ML;7.5MG/15ML	SOLUTION;ORAL	Prescription	No	AA	040838	PHARM ASSOC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG/15ML;7.5MG/15ML	SOLUTION;ORAL	Prescription	No	AA	211023	WES PHARMA INC

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