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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074330
Company: IVAX SUB TEVA PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/31/1994 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
03/30/2012 SUPPL-38 Labeling-Package Insert

Label is not available on this site.
04/28/2010 SUPPL-36 Labeling-Package Insert

Label is not available on this site.
09/18/2009 SUPPL-32 Labeling-Package Insert

Label is not available on this site.
04/12/2007 SUPPL-27 Manufacturing (CMC)-Facility

Label is not available on this site.
09/05/2002 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.
03/26/2002 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.
09/12/2001 SUPPL-21 Manufacturing (CMC)-Facility

Label is not available on this site.
03/21/2001 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
08/10/2000 SUPPL-19 Manufacturing (CMC)-Facility

Label is not available on this site.
02/06/2001 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.
11/28/2000 SUPPL-17 Manufacturing (CMC)-Facility

Label is not available on this site.
10/06/2000 SUPPL-16 Labeling

Label is not available on this site.
08/10/2000 SUPPL-15 Manufacturing (CMC)-Facility

Label is not available on this site.
06/07/2001 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
10/06/2000 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.
06/28/2000 SUPPL-12 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.
10/06/2000 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.
07/22/1999 SUPPL-10 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.
07/01/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
10/06/1998 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
04/26/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
04/26/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
04/26/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
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