Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077723
Company: STRIDES PHARMA

• 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	Discontinued	None	No	No
HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	7.5MG;200MG	TABLET;ORAL	Discontinued	None	No	No
HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	10MG;200MG	TABLET;ORAL	Discontinued	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
12/22/2025	SUPPL-37	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/21/2024	SUPPL-36	Labeling-Package Insert		Label is not available on this site.
10/31/2024	SUPPL-35	REMS - MODIFIED - D-N-A		Label is not available on this site.
10/03/2024	SUPPL-34	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/15/2023	SUPPL-33	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/15/2023	SUPPL-32	Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
09/02/2021	SUPPL-31	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Patient 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-Package Insert, Labeling-Medication Guide		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-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/03/2015	SUPPL-16	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
04/23/2013	SUPPL-9	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels		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.