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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201067
Company: MYLAN

Products on ANDA 201067

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISRADIPINE	ISRADIPINE	5MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
ISRADIPINE	ISRADIPINE	10MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201067

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/27/2015	ORIG-1	Approval	Not Applicable			Label is not available on this site.

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