Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076740
Company: BIONPHARMA

Products on ANDA 076740

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NIMODIPINE	NIMODIPINE	30MG	CAPSULE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076740

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/17/2008	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/076740Orig1s000BioeqR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2012	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076740

NIMODIPINE

CAPSULE;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NIMODIPINE	NIMODIPINE	30MG	CAPSULE;ORAL	Prescription	No	AB	076740	BIONPHARMA
NIMODIPINE	NIMODIPINE	30MG	CAPSULE;ORAL	Prescription	No	AB	077811	HERITAGE
NIMODIPINE	NIMODIPINE	30MG	CAPSULE;ORAL	Prescription	No	AB	090103	THEPHARMANETWORK LLC