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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071881
Company: HERITAGE PHARMS

Products on ANDA 071881

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071881

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.

Therapeutic Equivalents for ANDA 071881

VERAPAMIL HYDROCHLORIDE

TABLET;ORAL; 120MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	120MG	TABLET;ORAL	Prescription	No	AB	071881	HERITAGE PHARMS
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
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
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	80MG	TABLET;ORAL	Prescription	No	AB	070995	WATSON LABS

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