Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090118
Company: SUN PHARM INDS INC

• REMS

Products on ANDA 090118

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	Discontinued	None	No	No
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;7.5MG	TABLET;ORAL	Discontinued	None	No	No
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;10MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090118

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/23/2008	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
12/15/2023	SUPPL-34	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/04/2021	SUPPL-33	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/11/2019	SUPPL-32	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/21/2018	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-27	REMS - PROPOSAL - D-N-A		Label is not available on this site.
12/16/2016	SUPPL-24	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/16/2016	SUPPL-23	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/16/2016	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
12/15/2016	SUPPL-16	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
12/15/2016	SUPPL-14	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
10/25/2013	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
06/27/2011	SUPPL-2	Labeling-Package Insert		Label is not available on this site.