Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074587
Company: MYLAN
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
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 180MG 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
03/23/1996 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
09/24/2019 SUPPL-40 Labeling-Package Insert

Label is not available on this site.

09/24/2019 SUPPL-39 Labeling-Package Insert

Label is not available on this site.

10/15/2015 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

10/15/2015 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

07/31/2010 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

03/15/2010 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

03/21/2008 SUPPL-25 Labeling

Label is not available on this site.

07/25/2002 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/2002 SUPPL-18 Labeling

Label is not available on this site.

03/30/2001 SUPPL-17 Labeling

Label is not available on this site.

10/05/2000 SUPPL-16 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/05/2000 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/2000 SUPPL-14 Labeling

Label is not available on this site.

10/05/2000 SUPPL-13 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

05/18/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/19/1997 SUPPL-11 Labeling

Label is not available on this site.

09/19/1997 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/19/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/19/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/19/1997 SUPPL-7 Manufacturing (CMC)-New Strength

Label is not available on this site.

02/21/1997 SUPPL-6 Labeling

Label is not available on this site.

02/21/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/21/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/21/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/15/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/21/1997 SUPPL-1 Manufacturing (CMC)-New Strength

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

TABLET, EXTENDED RELEASE;ORAL; 180MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206173 CADILA PHARMS LTD
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090700 GLENMARK GENERICS
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 074330 IVAX SUB TEVA PHARMS
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 074587 MYLAN
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090529 SUN PHARM INDS INC

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