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VERELAN

NDA

VERAPAMIL HYDROCHLORIDE | N019614 | AZURITY PHARMACEUTICALS INC

4 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain9 active DMFs8 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPAVERAPAMIL HYDROCHLORIDE

DMF 48021983

ABBOTT LABORATORIESVERAPAMIL HYDROCHLORIDE

DMF 70001987

TAPI NL BVVERAPAMIL HYDROCHLORIDE

DMF 86711990

PIRAMAL PHARMA LTDVERAPAMIL HYDROCHLORIDE

DMF 166052003

MATRIX PHARMACORP PRIVATE LTDVERAPAMIL HYDROCHLORIDE USP

DMF 322932017

AURORE LIFE SCIENCES PRIVATE LTDVERAPAMIL HYDROCHLORIDE USP

DMF 340432019

COHANCE LIFESCIENCES LTDVERAPAMIL HYDROCHLORIDE USP

DMF 343412019

ALIVUS LIFE SCIENCES LTDVERAPAMIL HYDROCHLORIDE USP

DMF 356912021

DASAMI LAB PRIVATE LTDVERAPAMIL HYDROCHLORIDE USP

DMF 368082022

FINE CHEMICALS CORPInactiveVERAPAMIL HYDROCHLORIDE

DMF 51411983

GANES CHEMICALS INC PENNSVILLE DIVInactiveVERAPAMIL HYDROCHLORIDE

DMF 52271983

SELOC AGInactiveVERAPAMIL HYDROCHLORIDE

DMF 55641984

CHINOIN PHARMACEUTCIAL AND CHEMICAL WORKS CO LTDInactiveVERAPAMIL HYDROCHLORIDE

DMF 62081986

SIBEFAT SPAInactiveVERAPAMIL HYDROCHLORIDE

DMF 67081986

ALFA CHEMICALS ITALIANA SRLInactiveVERAPAMIL HYDROCHLORIDE

DMF 72441987

CHEMISCHE FABRIK WEYL GMBHInactiveVERAPAMIL HYDROCHLORIDE

DMF 74551988

DIVIS LABORATORIES LTDInactiveVERAPAMIL HYDROCHLORIDE USP

DMF 185232005

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Oct 2, 2019	SUPPL -56	View Letter (PDF)
Nov 22, 2016	SUPPL -53	View Letter (PDF)
Oct 10, 2014	SUPPL -50	View Letter (PDF)
Nov 16, 2011	SUPPL -49	View Letter (PDF)
Apr 9, 2010	SUPPL -34	View Letter (PDF)
Apr 2, 2010	SUPPL -45	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 120MG

RLDAB

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: May 29, 1990

No patent or exclusivity listings for this strength.

#002 — 240MG

RLDAB

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: May 29, 1990

#003 — 180MG

RLDAB

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Jan 9, 1992

#004 — 360MG

RLD

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: May 10, 1996