Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073250
Company: LEADING

Products on ANDA 073250

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NIFEDIPINE	NIFEDIPINE	10MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 073250

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/08/1991	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-10	Labeling-Package Insert		Label is not available on this site.
06/19/2001	SUPPL-7	Manufacturing (CMC)-Facility		Label is not available on this site.
12/31/1998	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
06/12/1998	SUPPL-5	Labeling		Label is not available on this site.
01/24/1997	SUPPL-4	Labeling		Label is not available on this site.
07/26/1996	SUPPL-3	Labeling		Label is not available on this site.
07/31/1996	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
03/24/1992	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 073250

NIFEDIPINE

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NIFEDIPINE	NIFEDIPINE	10MG	CAPSULE;ORAL	Prescription	No	AB	072781	ACELLA
NIFEDIPINE	NIFEDIPINE	10MG	CAPSULE;ORAL	Prescription	No	AB	072579	ACTAVIS ELIZABETH
NIFEDIPINE	NIFEDIPINE	10MG	CAPSULE;ORAL	Prescription	No	AB	202644	HERITAGE PHARMA
NIFEDIPINE	NIFEDIPINE	10MG	CAPSULE;ORAL	Prescription	No	AB	073250	LEADING
PROCARDIA	NIFEDIPINE	10MG	CAPSULE;ORAL	Prescription	Yes	AB	018482	PFIZER