Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074045
Company: LEADING

Products on ANDA 074045

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NIFEDIPINE	NIFEDIPINE	20MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074045

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/1992	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
05/21/2018	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
10/02/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
06/19/2001	SUPPL-5	Manufacturing (CMC)-Facility		Label is not available on this site.
12/31/1998	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/28/1997	SUPPL-3	Labeling		Label is not available on this site.
07/26/1996	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 074045

NIFEDIPINE

CAPSULE;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NIFEDIPINE	NIFEDIPINE	20MG	CAPSULE;ORAL	Prescription	No	AB	072556	ACTAVIS ELIZABETH
NIFEDIPINE	NIFEDIPINE	20MG	CAPSULE;ORAL	Prescription	No	AB	202644	HERITAGE PHARMA
NIFEDIPINE	NIFEDIPINE	20MG	CAPSULE;ORAL	Prescription	No	AB	074045	LEADING