Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216256
Company: AMNEAL PHARMS LLC

Products on ANDA 216256

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NIMODIPINE	NIMODIPINE	30MG/5ML(6MG/ML)	SOLUTION;ORAL	None (Tentative Approval)	None	No	No
NIMODIPINE	NIMODIPINE	60MG/10ML(6MG/ML)	SOLUTION;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216256

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/14/2024	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.