Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 072781
Company: ACELLA

Products on ANDA 072781

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 072781

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/30/1993	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
09/02/2009	SUPPL-11	Labeling		Label is not available on this site.
12/09/1994	SUPPL-7	Labeling		Label is not available on this site.
12/09/1994	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 072781

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