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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077811
Company: HERITAGE

Products on ANDA 077811

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077811

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/02/2007	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/21/2013	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077811

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

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