Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077723
Company: NOSTRUM LABS INC

• REMS

Products on ANDA 077723

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCODONE	HYDROCODONE BITARTRATE; IBUPROFEN	5MG;200MG	TABLET;ORAL	Prescription	AB	No	No
HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	7.5MG;200MG	TABLET;ORAL	Prescription	AB	No	No
HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	10MG;200MG	TABLET;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077723

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/06/2006	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-33	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-32	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Patient Package Insert		Label is not available on this site.
09/02/2021	SUPPL-31	Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
04/30/2021	SUPPL-30	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-29	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/11/2019	SUPPL-27	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/22/2019	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
09/21/2018	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-21	REMS - PROPOSAL - D-N-A		Label is not available on this site.
09/14/2018	SUPPL-19	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/03/2015	SUPPL-16	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
04/23/2013	SUPPL-9	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.
04/03/2015	SUPPL-4	Labeling		Label is not available on this site.
04/03/2007	SUPPL-2	Labeling		Label is not available on this site.
12/31/2007	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077723

HYDROCODONE

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCODONE	HYDROCODONE BITARTRATE; IBUPROFEN	5MG;200MG	TABLET;ORAL	Prescription	No	AB	077723	NOSTRUM LABS INC
HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	5MG;200MG	TABLET;ORAL	Prescription	No	AB	076642	AMNEAL PHARMS NY

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