Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078906
Company: GLENMARK PHARMS LTD

Products on ANDA 078906

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078906

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/17/2009	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
12/22/2021	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
09/26/2019	SUPPL-9	Labeling-Container/Carton Labels		Label is not available on this site.
09/26/2019	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
04/06/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
04/06/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
09/07/2010	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078906

VERAPAMIL HYDROCHLORIDE

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
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 PHARMS LTD
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	075072	STRIDES PHARMA