Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203934
Company: ZYDUS PHARMS

Products on ANDA 203934

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 203934

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/24/2024	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203934Orig1s000TA_ltr.pdf

Therapeutic Equivalents for ANDA 203934

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	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	218075	ANNORA PHARMA
GABAPENTIN	GABAPENTIN	600MG	TABLET;ORAL	Prescription	No	AB2	216252	HUMANWELL
GABAPENTIN	GABAPENTIN	600MG	TABLET;ORAL	Prescription	No	AB2	203934	ZYDUS PHARMS
GRALISE	GABAPENTIN	600MG	TABLET;ORAL	Prescription	Yes	AB2	022544	ALMATICA