Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071881
Company: HERITAGE PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 120MG TABLET;ORAL Prescription AB No Yes
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 40MG 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
04/05/1988 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
11/17/2017 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

11/17/2017 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

04/18/2016 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

11/29/2011 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

07/29/2011 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

10/14/2015 SUPPL-5 Manufacturing (CMC)-New Strength Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/071881Orig1s005ltr.pdf
01/10/1992 SUPPL-3 Labeling

Label is not available on this site.

06/19/1990 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; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 071881 HERITAGE PHARMS INC
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 072924 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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