Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 220420
Company: ANNORA PHARMA PRIVATE LIMITED

Products on ANDA 220420

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GABAPENTIN ENACARBIL	GABAPENTIN ENACARBIL	300MG	TABLET, EXTENDED RELEASE	None (Tentative Approval)	None	No	No
GABAPENTIN ENACARBIL	GABAPENTIN ENACARBIL	600MG	TABLET, EXTENDED RELEASE	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 220420

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/20/2026	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.