Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 079135
Company: GLENMARK GENERICS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 2MG;180MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 2MG;240MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 4MG;240MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 1MG;240MG TABLET, EXTENDED RELEASE;ORAL Prescription 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
08/30/2010 ORIG-3 Approval

Label is not available on this site.

05/26/2010 ORIG-2 Approval

Label is not available on this site.

05/05/2010 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079135s003ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/01/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

05/01/2015 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

05/01/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 2MG;180MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TARKA TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 2MG;180MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020591 ABBVIE
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 2MG;180MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 079135 GLENMARK GENERICS

TABLET, EXTENDED RELEASE;ORAL; 2MG;240MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TARKA TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 2MG;240MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020591 ABBVIE
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 2MG;240MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 079135 GLENMARK GENERICS

TABLET, EXTENDED RELEASE;ORAL; 4MG;240MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TARKA TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 4MG;240MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020591 ABBVIE
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 4MG;240MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 079135 GLENMARK GENERICS

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