An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090700
Company: GLENMARK PHARMS LTD

Products on ANDA 090700

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	Yes
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	180MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090700

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/03/2011	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-7	Labeling-Package Insert		Label is not available on this site.
09/26/2019	SUPPL-6	Labeling-Container/Carton Labels		Label is not available on this site.
09/26/2019	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
04/09/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
04/09/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090700

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
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	206173	CADILA PHARMS LTD
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	090700	GLENMARK PHARMS LTD
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	075072	STRIDES PHARMA

TABLET, EXTENDED RELEASE;ORAL; 180MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	180MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	206173	CADILA PHARMS LTD
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	180MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	090700	GLENMARK PHARMS LTD

Top