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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075072
Company: STRIDES PHARMA

Products on ANDA 075072

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	No
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075072

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/25/1999	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75072_Verapamil_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75072ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75072_Verapamil.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/20/2002	SUPPL-6	Manufacturing (CMC)-Facility		Label is not available on this site.
05/20/2002	SUPPL-5	Manufacturing (CMC)-Facility		Label is not available on this site.
03/22/2002	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
08/21/2001	SUPPL-3	Labeling		Label is not available on this site.
02/14/2001	SUPPL-2	Labeling		Label is not available on this site.
06/24/1999	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for ANDA 075072

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/25/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75072_Verapamil_prntlbl.pdf

Therapeutic Equivalents for ANDA 075072

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; 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

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