Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075072
Company: PAR PHARM
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 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
05/25/1999 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75072_Verapamil_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75072ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75072_Verapamil.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/20/2002 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

05/20/2002 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

03/22/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/2001 SUPPL-3 Labeling

Label is not available on this site.

02/14/2001 SUPPL-2 Labeling

Label is not available on this site.

06/24/1999 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/25/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75072_Verapamil_prntlbl.pdf

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; 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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