Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040736
Company: AMNEAL PHARMS NY

• REMS

Products on ANDA 040736

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;5MG	TABLET;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040736

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/25/2006	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
12/15/2023	SUPPL-35	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-34	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/13/2023	SUPPL-31	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/13/2023	SUPPL-29	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-28	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/10/2019	SUPPL-21	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/21/2018	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-18	REMS - PROPOSAL - D-N-A		Label is not available on this site.
12/16/2016	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-16	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/05/2016	SUPPL-14	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
04/04/2014	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
06/24/2011	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
04/26/2013	SUPPL-8	Labeling		Label is not available on this site.
03/20/2008	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.

Therapeutic Equivalents for ANDA 040736

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

TABLET;ORAL; 325MG;5MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ANEXSIA 5/325	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;5MG	TABLET;ORAL	Prescription	No	AA	040409	SPECGX LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;5MG	TABLET;ORAL	Prescription	No	AA	209037	ABHAI LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;5MG	TABLET;ORAL	Prescription	No	AA	040736	AMNEAL PHARMS NY
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;5MG	TABLET;ORAL	Prescription	No	AA	211487	ASCENT PHARMS INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;5MG	TABLET;ORAL	Prescription	No	AA	201013	AUROLIFE PHARMA LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;5MG	TABLET;ORAL	Prescription	No	AA	203863	EPIC PHARMA LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;5MG	TABLET;ORAL	Prescription	No	AA	202991	RHODES PHARMS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;5MG	TABLET;ORAL	Prescription	No	AA	040655	STRIDES PHARMA
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;5MG	TABLET;ORAL	Prescription	No	AA	202935	STRIDES PHARMA
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;5MG	TABLET;ORAL	Prescription	No	AA	202214	TRIS PHARMA INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;5MG	TABLET;ORAL	Prescription	No	AA	210211	WES PHARMA INC