Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072651
Company: TEVA

Products on ANDA 072651

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NIFEDIPINE	NIFEDIPINE	10MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072651

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/19/1992	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
01/19/2000	SUPPL-17	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
06/12/1998	SUPPL-16	Labeling		Label is not available on this site.
12/22/1997	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
11/14/1996	SUPPL-14	Labeling		Label is not available on this site.
05/16/1996	SUPPL-13	Labeling		Label is not available on this site.
04/21/1994	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
05/24/1994	SUPPL-11	Labeling		Label is not available on this site.
11/10/1993	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
11/10/1993	SUPPL-9	Labeling		Label is not available on this site.
11/10/1993	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
11/10/1993	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
12/14/1992	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
01/04/1993	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
01/04/1993	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/04/1993	SUPPL-3	Labeling		Label is not available on this site.
04/16/1992	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
04/16/1992	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.