Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071483
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 120MG TABLET;ORAL Prescription AB No No
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 80MG TABLET;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
02/15/1989 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
09/27/2019 SUPPL-27 Labeling-Package Insert, Labeling

Label is not available on this site.

09/27/2019 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

11/09/2015 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

11/21/2012 SUPPL-23 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

08/25/1998 SUPPL-12 Labeling

Label is not available on this site.

02/05/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/16/1997 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/22/1995 SUPPL-8 Labeling

Label is not available on this site.

08/22/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/22/1993 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/27/1992 SUPPL-4 Labeling

Label is not available on this site.

01/25/1991 SUPPL-3 Labeling

Label is not available on this site.

01/31/1990 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/13/1989 SUPPL-1 Labeling

Label is not available on this site.

VERAPAMIL HYDROCHLORIDE

TABLET;ORAL; 120MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CALAN VERAPAMIL HYDROCHLORIDE 120MG TABLET;ORAL Prescription Yes AB 018817 GD SEARLE LLC
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB 071881 HERITAGE PHARMS INC
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB 071483 MYLAN
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB 070994 WATSON LABS

TABLET;ORAL; 80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB 071881 HERITAGE PHARMS INC
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB 071483 MYLAN
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB 070995 WATSON LABS

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