Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216252
Company: HUMANWELL

Products on ANDA 216252

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GABAPENTIN	GABAPENTIN	300MG	TABLET;ORAL	Prescription	AB2	No	No
GABAPENTIN	GABAPENTIN	600MG	TABLET;ORAL	Prescription	AB2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216252

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/26/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/07/2026	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/07/2026	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 216252

GABAPENTIN

TABLET;ORAL; 300MG
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GABAPENTIN	GABAPENTIN	300MG	TABLET;ORAL	Prescription	No	AB2	218075	ANNORA PHARMA
GABAPENTIN	GABAPENTIN	300MG	TABLET;ORAL	Prescription	No	AB2	216252	HUMANWELL
GABAPENTIN	GABAPENTIN	300MG	TABLET;ORAL	Prescription	No	AB2	218491	SCIEGEN PHARMS
GABAPENTIN	GABAPENTIN	300MG	TABLET;ORAL	Prescription	No	AB2	203934	ZYDUS PHARMS
GRALISE	GABAPENTIN	300MG	TABLET;ORAL	Prescription	Yes	AB2	022544	ALMATICA

TABLET;ORAL; 600MG
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GABAPENTIN	GABAPENTIN	600MG	TABLET;ORAL	Prescription	No	AB2	203643	ABON PHARMS LLC
GABAPENTIN	GABAPENTIN	600MG	TABLET;ORAL	Prescription	No	AB2	218075	ANNORA PHARMA
GABAPENTIN	GABAPENTIN	600MG	TABLET;ORAL	Prescription	No	AB2	216252	HUMANWELL
GABAPENTIN	GABAPENTIN	600MG	TABLET;ORAL	Prescription	No	AB2	218491	SCIEGEN PHARMS
GABAPENTIN	GABAPENTIN	600MG	TABLET;ORAL	Prescription	No	AB2	203934	ZYDUS PHARMS
GRALISE	GABAPENTIN	600MG	TABLET;ORAL	Prescription	Yes	AB2	022544	ALMATICA