Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213501
Company: GLENMARK PHARMS LTD

Products on ANDA 213501

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213501

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/29/2020	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.