Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 073568
Company: IVAX SUB TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;ORAL Prescription AB 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
07/31/1992 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
03/30/2012 SUPPL-67 Labeling-Package Insert

Label is not available on this site.

04/28/2010 SUPPL-65 Labeling-Package Insert

Label is not available on this site.

09/18/2009 SUPPL-61 Labeling-Package Insert

Label is not available on this site.

12/09/2002 SUPPL-49 Manufacturing (CMC)-Facility

Label is not available on this site.

09/05/2002 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/2002 SUPPL-47 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/12/2001 SUPPL-46 Manufacturing (CMC)-Facility

Label is not available on this site.

02/06/2001 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

11/28/2000 SUPPL-43 Manufacturing (CMC)-Facility

Label is not available on this site.

08/14/2000 SUPPL-42 Manufacturing (CMC)-Facility

Label is not available on this site.

03/21/2001 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

05/15/2002 SUPPL-40 Manufacturing (CMC)-Facility

Label is not available on this site.

05/15/2002 SUPPL-38 Manufacturing (CMC)-Facility

Label is not available on this site.

10/06/2000 SUPPL-37 Labeling

Label is not available on this site.

08/14/2000 SUPPL-36 Manufacturing (CMC)-Facility

Label is not available on this site.

06/07/2001 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

06/16/2000 SUPPL-34 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

06/29/2000 SUPPL-33 Manufacturing (CMC)-Facility

Label is not available on this site.

10/06/2000 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/06/2000 SUPPL-31 Manufacturing (CMC)-Facility

Label is not available on this site.

10/06/2000 SUPPL-30 Manufacturing (CMC)-Facility

Label is not available on this site.

07/01/1999 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

07/01/1999 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

07/01/1999 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

10/06/1998 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

10/10/1997 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

10/10/1997 SUPPL-23 Labeling

Label is not available on this site.

10/10/1997 SUPPL-22 Manufacturing (CMC)-New Strength

Label is not available on this site.

05/19/1997 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

04/26/1996 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/26/1996 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/26/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/04/1994 SUPPL-14 Labeling

Label is not available on this site.

07/25/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/02/1994 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/02/1994 SUPPL-11 Labeling

Label is not available on this site.

06/02/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/13/1993 SUPPL-9 Labeling

Label is not available on this site.

07/14/1993 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/13/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/13/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/24/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/24/1992 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/24/1992 SUPPL-2 Labeling

Label is not available on this site.

VERAPAMIL HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 240MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CALAN SR VERAPAMIL HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 019152 PFIZER
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206173 CADILA PHARMS LTD
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078906 GLENMARK GENERICS
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 073568 IVAX SUB TEVA PHARMS
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 074587 MYLAN
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075072 PAR PHARM
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090529 SUN PHARM INDS INC

TABLET, EXTENDED RELEASE;ORAL; 120MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CALAN SR VERAPAMIL HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 019152 PFIZER
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090700 GLENMARK GENERICS
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 073568 IVAX SUB TEVA PHARMS
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 074587 MYLAN
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075072 PAR PHARM
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090529 SUN PHARM INDS INC

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English