Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090529
Company: SUN PHARM INDS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 240MG 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
12/30/2011 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-13 Labeling-Package Insert

Label is not available on this site.

09/24/2019 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

VERAPAMIL HYDROCHLORIDE

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

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

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