Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076017
Company: IVAX SUB TEVA PHARMS

Products on ANDA 076017

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GABAPENTIN	GABAPENTIN	100MG	TABLET;ORAL	Prescription	AB1	No	No
GABAPENTIN	GABAPENTIN	300MG	TABLET;ORAL	Prescription	AB1	No	No
GABAPENTIN	GABAPENTIN	400MG	TABLET;ORAL	Prescription	AB1	No	No
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 076017

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/28/2004	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76017ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/20/2015	SUPPL-39	Labeling-Package Insert		Label is not available on this site.
07/20/2015	SUPPL-38	Labeling-Package Insert		Label is not available on this site.
09/25/2014	SUPPL-37	Labeling-Package Insert		Label is not available on this site.
07/19/2012	SUPPL-35	Labeling-Package Insert		Label is not available on this site.
04/16/2012	SUPPL-34	Labeling-Package Insert		Label is not available on this site.
09/29/2011	SUPPL-33	Labeling-Package Insert		Label is not available on this site.
08/25/2011	SUPPL-30	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
11/18/2009	SUPPL-25	Labeling		Label is not available on this site.
07/14/2008	SUPPL-24	Labeling		Label is not available on this site.
04/28/2008	SUPPL-22	Labeling		Label is not available on this site.
01/17/2008	SUPPL-20	Labeling		Label is not available on this site.
12/20/2005	SUPPL-12	Labeling		Label is not available on this site.
04/29/2005	SUPPL-9			Label is not available on this site.
04/29/2005	SUPPL-6	Labeling		Label is not available on this site.
04/29/2005	SUPPL-5			Label is not available on this site.
04/29/2005	SUPPL-4			Label is not available on this site.
09/20/2004	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076017

GABAPENTIN

TABLET;ORAL; 100MG
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GABAPENTIN	GABAPENTIN	100MG	TABLET;ORAL	Prescription	No	AB1	077894	APOTEX
GABAPENTIN	GABAPENTIN	100MG	TABLET;ORAL	Prescription	No	AB1	076017	IVAX SUB TEVA PHARMS

TABLET;ORAL; 300MG
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GABAPENTIN	GABAPENTIN	300MG	TABLET;ORAL	Prescription	No	AB1	077894	APOTEX
GABAPENTIN	GABAPENTIN	300MG	TABLET;ORAL	Prescription	No	AB1	076017	IVAX SUB TEVA PHARMS

TABLET;ORAL; 400MG
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GABAPENTIN	GABAPENTIN	400MG	TABLET;ORAL	Prescription	No	AB1	077894	APOTEX
GABAPENTIN	GABAPENTIN	400MG	TABLET;ORAL	Prescription	No	AB1	076017	IVAX SUB TEVA PHARMS