Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076604
Company: ACTAVIS LABS FL INC

• REMS

Products on ANDA 076604

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	7.5MG;200MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076604

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/31/2003	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
10/03/2024	SUPPL-28	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-27	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/15/2023	SUPPL-26	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/28/2021	SUPPL-25	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-24	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/11/2019	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/23/2019	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
09/21/2018	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-20	REMS - PROPOSAL - D-N-A		Label is not available on this site.
03/22/2017	SUPPL-19	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/22/2017	SUPPL-18	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
07/31/2010	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
08/22/2007	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076604

HYDROCODONE BITARTRATE AND IBUPROFEN

TABLET;ORAL; 7.5MG;200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	7.5MG;200MG	TABLET;ORAL	Prescription	No	AB	076604	ACTAVIS LABS FL INC
HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	7.5MG;200MG	TABLET;ORAL	Prescription	No	AB	076642	AMNEAL PHARMS NY
HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	7.5MG;200MG	TABLET;ORAL	Prescription	No	AB	204575	AUROLIFE PHARMA LLC
HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	7.5MG;200MG	TABLET;ORAL	Prescription	No	AB	077723	NOSTRUM LABS INC