Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213409
Company: ALKEM LABS LTD

Products on ANDA 213409

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213409

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/22/2025	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213409Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 213409

NIMODIPINE

SOLUTION;ORAL; 6MG/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NIMODIPINE	NIMODIPINE	6MG/ML	SOLUTION;ORAL	Prescription	No	AB	213409	ALKEM LABS LTD
NYMALIZE	NIMODIPINE	6MG/ML	SOLUTION;ORAL	Prescription	Yes	AB	203340	AZURITY