Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075694
Company: ACTAVIS ELIZABETH

• Healthcare Professional Sheet

Products on ANDA 075694

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GABAPENTIN	GABAPENTIN	600MG	TABLET;ORAL	Discontinued	None	No	No
GABAPENTIN	GABAPENTIN	800MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075694

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/21/2004	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
09/12/2025	SUPPL-57	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/17/2024	SUPPL-56	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/19/2022	SUPPL-53	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/19/2022	SUPPL-50	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/19/2022	SUPPL-49	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/19/2022	SUPPL-43	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/19/2022	SUPPL-42	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/04/2016	SUPPL-37	Labeling-Package Insert		Label is not available on this site.
01/04/2016	SUPPL-34	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/03/2014	SUPPL-31	Labeling-Package Insert		Label is not available on this site.
01/04/2016	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
04/11/2012	SUPPL-24	REMS-Proposal, Labeling-Package Insert		Label is not available on this site.
08/29/2011	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
03/30/2011	SUPPL-20	REMS-Proposal		Label is not available on this site.
11/18/2009	SUPPL-16	Labeling		Label is not available on this site.
12/23/2005	SUPPL-5	Labeling		Label is not available on this site.
05/17/2005	SUPPL-1	Labeling		Label is not available on this site.