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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214956
Company: ASCENT PHARMS INC

Products on ANDA 214956

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214956

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/10/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 214956

GABAPENTIN

CAPSULE;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GABAPENTIN	GABAPENTIN	100MG	CAPSULE;ORAL	Prescription	No	AB	075350	ACTAVIS ELIZABETH
GABAPENTIN	GABAPENTIN	100MG	CAPSULE;ORAL	Prescription	No	AB	090858	ALKEM
GABAPENTIN	GABAPENTIN	100MG	CAPSULE;ORAL	Prescription	No	AB	078428	AMNEAL PHARMS NY
GABAPENTIN	GABAPENTIN	100MG	CAPSULE;ORAL	Prescription	No	AB	214956	ASCENT PHARMS INC
GABAPENTIN	GABAPENTIN	100MG	CAPSULE;ORAL	Prescription	No	AB	078787	AUROBINDO PHARMA
GABAPENTIN	GABAPENTIN	100MG	CAPSULE;ORAL	Prescription	No	AB	075477	CSPC OUYI
GABAPENTIN	GABAPENTIN	100MG	CAPSULE;ORAL	Prescription	No	AB	075360	GRANULES
GABAPENTIN	GABAPENTIN	100MG	CAPSULE;ORAL	Prescription	No	AB	090705	INVAGEN PHARMS
GABAPENTIN	GABAPENTIN	100MG	CAPSULE;ORAL	Prescription	No	AB	217546	LAURUS
GABAPENTIN	GABAPENTIN	100MG	CAPSULE;ORAL	Prescription	No	AB	090007	MARKSANS PHARMA
GABAPENTIN	GABAPENTIN	100MG	CAPSULE;ORAL	Prescription	No	AB	219814	PRINSTON INC
GABAPENTIN	GABAPENTIN	100MG	CAPSULE;ORAL	Prescription	No	AB	207099	RISING
GABAPENTIN	GABAPENTIN	100MG	CAPSULE;ORAL	Prescription	No	AB	219319	SENORES PHARMS
GABAPENTIN	GABAPENTIN	100MG	CAPSULE;ORAL	Prescription	No	AB	206943	STRIDES PHARMA
GABAPENTIN	GABAPENTIN	100MG	CAPSULE;ORAL	Prescription	No	AB	211314	STRIDES PHARMA
GABAPENTIN	GABAPENTIN	100MG	CAPSULE;ORAL	Prescription	No	AB	213603	ZHEJIANG YONGTAI
NEURONTIN	GABAPENTIN	100MG	CAPSULE;ORAL	Prescription	Yes	AB	020235	VIATRIS
RELGAABI	GABAPENTIN	100MG	CAPSULE;ORAL	Prescription	No	AB	204989	SCIEGEN PHARMS

CAPSULE;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GABAPENTIN	GABAPENTIN	300MG	CAPSULE;ORAL	Prescription	No	AB	075350	ACTAVIS ELIZABETH
GABAPENTIN	GABAPENTIN	300MG	CAPSULE;ORAL	Prescription	No	AB	090858	ALKEM
GABAPENTIN	GABAPENTIN	300MG	CAPSULE;ORAL	Prescription	No	AB	078428	AMNEAL PHARMS NY
GABAPENTIN	GABAPENTIN	300MG	CAPSULE;ORAL	Prescription	No	AB	214956	ASCENT PHARMS INC
GABAPENTIN	GABAPENTIN	300MG	CAPSULE;ORAL	Prescription	No	AB	078787	AUROBINDO PHARMA
GABAPENTIN	GABAPENTIN	300MG	CAPSULE;ORAL	Prescription	No	AB	075477	CSPC OUYI
GABAPENTIN	GABAPENTIN	300MG	CAPSULE;ORAL	Prescription	No	AB	075360	GRANULES
GABAPENTIN	GABAPENTIN	300MG	CAPSULE;ORAL	Prescription	No	AB	090705	INVAGEN PHARMS
GABAPENTIN	GABAPENTIN	300MG	CAPSULE;ORAL	Prescription	No	AB	217546	LAURUS
GABAPENTIN	GABAPENTIN	300MG	CAPSULE;ORAL	Prescription	No	AB	090007	MARKSANS PHARMA
GABAPENTIN	GABAPENTIN	300MG	CAPSULE;ORAL	Prescription	No	AB	219814	PRINSTON INC
GABAPENTIN	GABAPENTIN	300MG	CAPSULE;ORAL	Prescription	No	AB	207099	RISING
GABAPENTIN	GABAPENTIN	300MG	CAPSULE;ORAL	Prescription	No	AB	219319	SENORES PHARMS
GABAPENTIN	GABAPENTIN	300MG	CAPSULE;ORAL	Prescription	No	AB	206943	STRIDES PHARMA
GABAPENTIN	GABAPENTIN	300MG	CAPSULE;ORAL	Prescription	No	AB	211314	STRIDES PHARMA
GABAPENTIN	GABAPENTIN	300MG	CAPSULE;ORAL	Prescription	No	AB	213603	ZHEJIANG YONGTAI
NEURONTIN	GABAPENTIN	300MG	CAPSULE;ORAL	Prescription	Yes	AB	020235	VIATRIS
RELGAABI	GABAPENTIN	300MG	CAPSULE;ORAL	Prescription	No	AB	204989	SCIEGEN PHARMS

CAPSULE;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GABAPENTIN	GABAPENTIN	400MG	CAPSULE;ORAL	Prescription	No	AB	075350	ACTAVIS ELIZABETH
GABAPENTIN	GABAPENTIN	400MG	CAPSULE;ORAL	Prescription	No	AB	090858	ALKEM
GABAPENTIN	GABAPENTIN	400MG	CAPSULE;ORAL	Prescription	No	AB	078428	AMNEAL PHARMS NY
GABAPENTIN	GABAPENTIN	400MG	CAPSULE;ORAL	Prescription	No	AB	214956	ASCENT PHARMS INC
GABAPENTIN	GABAPENTIN	400MG	CAPSULE;ORAL	Prescription	No	AB	078787	AUROBINDO PHARMA
GABAPENTIN	GABAPENTIN	400MG	CAPSULE;ORAL	Prescription	No	AB	075477	CSPC OUYI
GABAPENTIN	GABAPENTIN	400MG	CAPSULE;ORAL	Prescription	No	AB	075360	GRANULES
GABAPENTIN	GABAPENTIN	400MG	CAPSULE;ORAL	Prescription	No	AB	090705	INVAGEN PHARMS
GABAPENTIN	GABAPENTIN	400MG	CAPSULE;ORAL	Prescription	No	AB	217546	LAURUS
GABAPENTIN	GABAPENTIN	400MG	CAPSULE;ORAL	Prescription	No	AB	090007	MARKSANS PHARMA
GABAPENTIN	GABAPENTIN	400MG	CAPSULE;ORAL	Prescription	No	AB	219814	PRINSTON INC
GABAPENTIN	GABAPENTIN	400MG	CAPSULE;ORAL	Prescription	No	AB	207099	RISING
GABAPENTIN	GABAPENTIN	400MG	CAPSULE;ORAL	Prescription	No	AB	219319	SENORES PHARMS
GABAPENTIN	GABAPENTIN	400MG	CAPSULE;ORAL	Prescription	No	AB	206943	STRIDES PHARMA
GABAPENTIN	GABAPENTIN	400MG	CAPSULE;ORAL	Prescription	No	AB	211314	STRIDES PHARMA
GABAPENTIN	GABAPENTIN	400MG	CAPSULE;ORAL	Prescription	No	AB	213603	ZHEJIANG YONGTAI
NEURONTIN	GABAPENTIN	400MG	CAPSULE;ORAL	Prescription	Yes	AB	020235	VIATRIS
RELGAABI	GABAPENTIN	400MG	CAPSULE;ORAL	Prescription	No	AB	204989	SCIEGEN PHARMS

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