Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075435
Company: TEVA PHARMS

Products on ANDA 075435

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 075435

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/08/2004	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75435ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/07/2026	SUPPL-30	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/07/2026	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
12/30/2011	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/30/2011	SUPPL-22	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.
05/13/2010	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
07/10/2013	SUPPL-18	Labeling		Label is not available on this site.
07/14/2009	SUPPL-13	Labeling		Label is not available on this site.
10/10/2007	SUPPL-7	Labeling		Label is not available on this site.
02/22/2007	SUPPL-5	Labeling		Label is not available on this site.
04/05/2006	SUPPL-3	Labeling		Label is not available on this site.