Drugs@FDA: FDA-Approved Drugs

Abbreviated New Drug Application (ANDA): 076642
Company: AMNEAL PHARMS NY

REMS

Products on ANDA 076642

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	Yes
HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	5MG;200MG	TABLET;ORAL	Prescription	AB	No	No
REPREXAIN	HYDROCODONE BITARTRATE; IBUPROFEN	2.5MG;200MG	TABLET;ORAL	Discontinued	None	No	No
REPREXAIN	HYDROCODONE BITARTRATE; IBUPROFEN	10MG;200MG	TABLET;ORAL	Discontinued	None	No	No

Showing 1 to 4 of 4 entries

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076642

Original Approvals or Tentative Approvals

CSV Excel Print

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
03/18/2004	ORIG-1	Approval			Review (PDF)	Label is not available on this site.

Showing 1 to 1 of 1 entries

Supplements

CSV Excel Print

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
11/21/2024	SUPPL-47	Labeling-Package Insert		Label is not available on this site.
10/31/2024	SUPPL-45	REMS - MODIFIED - D-N-A		Label is not available on this site.
10/03/2024	SUPPL-44	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/18/2023	SUPPL-42	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/18/2023	SUPPL-41	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/15/2023	SUPPL-35	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.
04/28/2021	SUPPL-32	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-30	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/10/2019	SUPPL-28	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/22/2019	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
09/21/2018	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-25	REMS - PROPOSAL - D-N-A		Label is not available on this site.
08/15/2018	SUPPL-23	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/15/2018	SUPPL-22	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/15/2018	SUPPL-20	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
03/20/2008	SUPPL-11	Manufacturing (CMC)-Facility		Label is not available on this site.
10/19/2007	SUPPL-8	Labeling	Letter (PDF)	Label is not available on this site.
10/19/2007	SUPPL-7	Manufacturing (CMC)-New Strength	Letter (PDF)	Label is not available on this site.
10/19/2007	SUPPL-6	Labeling	Letter (PDF)	Label is not available on this site.
10/19/2007	SUPPL-5	Manufacturing (CMC)-New Strength	Letter (PDF)	Label is not available on this site.
01/04/2007	SUPPL-10	Labeling		Label is not available on this site.
01/03/2007	SUPPL-9	Labeling		Label is not available on this site.
10/12/2004	SUPPL-3			Label is not available on this site.
06/16/2004	SUPPL-2	Labeling		Label is not available on this site.
04/05/2004	SUPPL-1	Labeling		Label is not available on this site.

Showing 1 to 25 of 25 entries

Therapeutic Equivalents for ANDA 076642

HYDROCODONE BITARTRATE AND IBUPROFEN

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

CSV Excel Print

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

Showing 1 to 3 of 3 entries

TABLET;ORAL; 5MG;200MG
TE Code = AB

CSV Excel Print

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	5MG;200MG	TABLET;ORAL	Prescription	No	AB	076642	AMNEAL PHARMS NY

Showing 1 to 1 of 1 entries

REPREXAIN

There are no Therapeutic Equivalents.