Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 078428
Company: AMNEAL PHARMS NY

Products on ANDA 078428

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 078428

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/25/2007	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-53	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.
08/02/2023	SUPPL-47	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/21/2020	SUPPL-43	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/21/2020	SUPPL-36	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
08/21/2020	SUPPL-33	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/08/2016	SUPPL-31	Labeling-Package Insert		Label is not available on this site.
11/08/2016	SUPPL-29	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/08/2016	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
11/08/2016	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
11/08/2016	SUPPL-26	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/08/2016	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
11/08/2016	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
04/23/2014	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
04/19/2012	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/30/2011	SUPPL-15	Labeling-Package Insert, REMS-Proposal, Labeling-Container/Carton Labels		Label is not available on this site.
12/16/2011	SUPPL-14	Labeling		Label is not available on this site.
04/17/2012	SUPPL-9	Labeling-Container/Carton Labels		Label is not available on this site.
05/17/2010	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
05/17/2010	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 078428

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	206943	ACI
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	207099	GRAVITI PHARMS
GABAPENTIN	GABAPENTIN	100MG	CAPSULE;ORAL	Prescription	No	AB	090705	INVAGEN PHARMS
GABAPENTIN	GABAPENTIN	100MG	CAPSULE;ORAL	Prescription	No	AB	208928	IPCA LABS LTD
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	204989	SCIEGEN PHARMS INC
GABAPENTIN	GABAPENTIN	100MG	CAPSULE;ORAL	Prescription	No	AB	211314	STRIDES PHARMA
GABAPENTIN	GABAPENTIN	100MG	CAPSULE;ORAL	Prescription	No	AB	077242	SUN PHARM INDS LTD
GABAPENTIN	GABAPENTIN	100MG	CAPSULE;ORAL	Prescription	No	AB	077261	TARO
GABAPENTIN	GABAPENTIN	100MG	CAPSULE;ORAL	Prescription	No	AB	213603	ZHEJIANG YONGTAI
NEURONTIN	GABAPENTIN	100MG	CAPSULE;ORAL	Prescription	Yes	AB	020235	VIATRIS

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	206943	ACI
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	207099	GRAVITI PHARMS
GABAPENTIN	GABAPENTIN	300MG	CAPSULE;ORAL	Prescription	No	AB	090705	INVAGEN PHARMS
GABAPENTIN	GABAPENTIN	300MG	CAPSULE;ORAL	Prescription	No	AB	208928	IPCA LABS LTD
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	204989	SCIEGEN PHARMS INC
GABAPENTIN	GABAPENTIN	300MG	CAPSULE;ORAL	Prescription	No	AB	211314	STRIDES PHARMA
GABAPENTIN	GABAPENTIN	300MG	CAPSULE;ORAL	Prescription	No	AB	077242	SUN PHARM INDS LTD
GABAPENTIN	GABAPENTIN	300MG	CAPSULE;ORAL	Prescription	No	AB	077261	TARO
GABAPENTIN	GABAPENTIN	300MG	CAPSULE;ORAL	Prescription	No	AB	213603	ZHEJIANG YONGTAI
NEURONTIN	GABAPENTIN	300MG	CAPSULE;ORAL	Prescription	Yes	AB	020235	VIATRIS

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	206943	ACI
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	207099	GRAVITI PHARMS
GABAPENTIN	GABAPENTIN	400MG	CAPSULE;ORAL	Prescription	No	AB	090705	INVAGEN PHARMS
GABAPENTIN	GABAPENTIN	400MG	CAPSULE;ORAL	Prescription	No	AB	208928	IPCA LABS LTD
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	204989	SCIEGEN PHARMS INC
GABAPENTIN	GABAPENTIN	400MG	CAPSULE;ORAL	Prescription	No	AB	211314	STRIDES PHARMA
GABAPENTIN	GABAPENTIN	400MG	CAPSULE;ORAL	Prescription	No	AB	077242	SUN PHARM INDS LTD
GABAPENTIN	GABAPENTIN	400MG	CAPSULE;ORAL	Prescription	No	AB	077261	TARO
GABAPENTIN	GABAPENTIN	400MG	CAPSULE;ORAL	Prescription	No	AB	213603	ZHEJIANG YONGTAI
NEURONTIN	GABAPENTIN	400MG	CAPSULE;ORAL	Prescription	Yes	AB	020235	VIATRIS