Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077317
Company: WATSON LABS TEVA

Products on ANDA 077317

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISRADIPINE	ISRADIPINE	2.5MG	CAPSULE;ORAL	Prescription	AB	No	No
ISRADIPINE	ISRADIPINE	5MG	CAPSULE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077317

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/05/2006	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 077317

ISRADIPINE

CAPSULE;ORAL; 2.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ISRADIPINE	ISRADIPINE	2.5MG	CAPSULE;ORAL	Prescription	No	AB	077169	ELITE LABS INC
ISRADIPINE	ISRADIPINE	2.5MG	CAPSULE;ORAL	Prescription	No	AB	077317	WATSON LABS TEVA

CAPSULE;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ISRADIPINE	ISRADIPINE	5MG	CAPSULE;ORAL	Prescription	No	AB	077169	ELITE LABS INC
ISRADIPINE	ISRADIPINE	5MG	CAPSULE;ORAL	Prescription	No	AB	077317	WATSON LABS TEVA