Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091001
Company: MYLAN

Products on ANDA 091001

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NISOLDIPINE	NISOLDIPINE	8.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
NISOLDIPINE	NISOLDIPINE	17MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
NISOLDIPINE	NISOLDIPINE	25.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	No	No
NISOLDIPINE	NISOLDIPINE	34MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091001

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/26/2011	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091001s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/11/2022	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091001

NISOLDIPINE

TABLET, EXTENDED RELEASE;ORAL; 8.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NISOLDIPINE	NISOLDIPINE	8.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	091001	MYLAN
SULAR	NISOLDIPINE	8.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	020356	AZURITY

TABLET, EXTENDED RELEASE;ORAL; 17MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NISOLDIPINE	NISOLDIPINE	17MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	216606	AMTA
NISOLDIPINE	NISOLDIPINE	17MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	091001	MYLAN
SULAR	NISOLDIPINE	17MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	020356	AZURITY