Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203244
Company: ACI

Products on ANDA 203244

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GABAPENTIN	GABAPENTIN	800MG	TABLET;ORAL	Prescription	AB1	No	No
GABAPENTIN	GABAPENTIN	600MG	TABLET;ORAL	Prescription	AB1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203244

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/12/2013	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
12/28/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
12/28/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203244

GABAPENTIN

TABLET;ORAL; 800MG
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GABAPENTIN	GABAPENTIN	800MG	TABLET;ORAL	Prescription	No	AB1	203244	ACI
GABAPENTIN	GABAPENTIN	800MG	TABLET;ORAL	Prescription	No	AB1	075694	ACTAVIS ELIZABETH
GABAPENTIN	GABAPENTIN	800MG	TABLET;ORAL	Prescription	No	AB1	206402	ALKEM LABS LTD
GABAPENTIN	GABAPENTIN	800MG	TABLET;ORAL	Prescription	No	AB1	214957	ASCENT PHARMS INC
GABAPENTIN	GABAPENTIN	800MG	TABLET;ORAL	Prescription	No	AB1	200651	AUROBINDO PHARMA LTD
GABAPENTIN	GABAPENTIN	800MG	TABLET;ORAL	Prescription	No	AB1	207057	CSPC OUYI
GABAPENTIN	GABAPENTIN	800MG	TABLET;ORAL	Prescription	No	AB1	077662	GLENMARK PHARMS LTD
GABAPENTIN	GABAPENTIN	800MG	TABLET;ORAL	Prescription	No	AB1	217116	GRANULES
GABAPENTIN	GABAPENTIN	800MG	TABLET;ORAL	Prescription	No	AB1	217965	LAURUS
GABAPENTIN	GABAPENTIN	800MG	TABLET;ORAL	Prescription	No	AB1	217995	RISING
GABAPENTIN	GABAPENTIN	800MG	TABLET;ORAL	Prescription	No	AB1	077661	RUBICON
GABAPENTIN	GABAPENTIN	800MG	TABLET;ORAL	Prescription	No	AB1	205101	SCIEGEN PHARMS INC
GABAPENTIN	GABAPENTIN	800MG	TABLET;ORAL	Prescription	No	AB1	211313	STRIDES PHARMA
GABAPENTIN	GABAPENTIN	800MG	TABLET;ORAL	Prescription	No	AB1	077525	SUN PHARM INDS LTD
GABAPENTIN	GABAPENTIN	800MG	TABLET;ORAL	Prescription	No	AB1	078926	ZYDUS PHARMS USA INC
NEURONTIN	GABAPENTIN	800MG	TABLET;ORAL	Prescription	Yes	AB1	020882	VIATRIS

TABLET;ORAL; 600MG
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GABAPENTIN	GABAPENTIN	600MG	TABLET;ORAL	Prescription	No	AB1	203244	ACI
GABAPENTIN	GABAPENTIN	600MG	TABLET;ORAL	Prescription	No	AB1	075694	ACTAVIS ELIZABETH
GABAPENTIN	GABAPENTIN	600MG	TABLET;ORAL	Prescription	No	AB1	206402	ALKEM LABS LTD
GABAPENTIN	GABAPENTIN	600MG	TABLET;ORAL	Prescription	No	AB1	214957	ASCENT PHARMS INC
GABAPENTIN	GABAPENTIN	600MG	TABLET;ORAL	Prescription	No	AB1	200651	AUROBINDO PHARMA LTD
GABAPENTIN	GABAPENTIN	600MG	TABLET;ORAL	Prescription	No	AB1	207057	CSPC OUYI
GABAPENTIN	GABAPENTIN	600MG	TABLET;ORAL	Prescription	No	AB1	077662	GLENMARK PHARMS LTD
GABAPENTIN	GABAPENTIN	600MG	TABLET;ORAL	Prescription	No	AB1	217116	GRANULES
GABAPENTIN	GABAPENTIN	600MG	TABLET;ORAL	Prescription	No	AB1	217965	LAURUS
GABAPENTIN	GABAPENTIN	600MG	TABLET;ORAL	Prescription	No	AB1	217995	RISING
GABAPENTIN	GABAPENTIN	600MG	TABLET;ORAL	Prescription	No	AB1	077661	RUBICON
GABAPENTIN	GABAPENTIN	600MG	TABLET;ORAL	Prescription	No	AB1	205101	SCIEGEN PHARMS INC
GABAPENTIN	GABAPENTIN	600MG	TABLET;ORAL	Prescription	No	AB1	211313	STRIDES PHARMA
GABAPENTIN	GABAPENTIN	600MG	TABLET;ORAL	Prescription	No	AB1	077525	SUN PHARM INDS LTD
GABAPENTIN	GABAPENTIN	600MG	TABLET;ORAL	Prescription	No	AB1	078926	ZYDUS PHARMS USA INC
NEURONTIN	GABAPENTIN	600MG	TABLET;ORAL	Prescription	Yes	AB1	020882	VIATRIS