Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090705
Company: INVAGEN PHARMS

Products on ANDA 090705

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 090705

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/30/2009	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
05/22/2025	SUPPL-37	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/18/2023	SUPPL-31	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/08/2020	SUPPL-27	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/08/2020	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
09/08/2020	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/03/2016	SUPPL-12	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
02/03/2016	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
02/03/2016	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
10/30/2014	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/11/2012	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
12/15/2011	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
08/29/2011	SUPPL-1	REMS-Proposal, Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 090705

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