Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077242
Company: SUN PHARM INDS LTD

Products on ANDA 077242

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GABAPENTIN	GABAPENTIN	100MG	CAPSULE;ORAL	Discontinued	None	No	No
GABAPENTIN	GABAPENTIN	300MG	CAPSULE;ORAL	Discontinued	None	No	No
GABAPENTIN	GABAPENTIN	400MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077242

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/24/2006	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
12/02/2024	SUPPL-31	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/02/2024	SUPPL-30	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/02/2024	SUPPL-28	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/27/2020	SUPPL-27	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/07/2020	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
08/07/2020	SUPPL-20	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/07/2020	SUPPL-19	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/10/2015	SUPPL-18	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/12/2014	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
12/12/2014	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
03/30/2011	SUPPL-10	REMS-Proposal		Label is not available on this site.
03/30/2011	SUPPL-9	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/13/2010	SUPPL-7	Labeling-Container/Carton Labels		Label is not available on this site.