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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077894
Company: APOTEX

Products on ANDA 077894

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077894

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/10/2006	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
08/02/2023	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
10/26/2020	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
10/26/2020	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
10/26/2020	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
10/26/2020	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
09/17/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
04/17/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
04/17/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
08/11/2010	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077894

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

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