Viewing data from:

CALAN

NDA

VERAPAMIL HYDROCHLORIDE | N018817 | PFIZER 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Camargo Pharmaceutical Services, LLC on behalf of Cente... FDA-2020-P-2245 Camargo Pharmaceutical Services, LLC, on behalf of Center Laboratories, Inc., filed this citizen petition requesting that the FDA determine that the discontinued formulations of CALAN (verapamil hydrochloride) 40, 80, 120, and 160 mg oral tablets under NDA 018817 from Pfizer Inc were not discontinue	505(q)	2020-12-01	Withdrawn	Camargo Pharmaceutical Services

Source: Regulations.gov. FDA citizen petitions matched by application number.

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

8 letters from Drugs@FDA

Date	Submission	Document
Nov 23, 2021	SUPPL -35	View Letter (PDF)
Sep 19, 2017	SUPPL -33	View Letter (PDF)
Aug 24, 2016	SUPPL -32	View Letter (PDF)
Oct 28, 2013	SUPPL -31	View Letter (PDF)
Nov 7, 2011	SUPPL -27	View Letter (PDF)
Jul 5, 2011	SUPPL -24	View Letter (PDF)
Apr 19, 2010	SUPPL -22	View Letter (PDF)
Jul 17, 2009	SUPPL -21	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 10, 1984

No patent or exclusivity listings for this strength.

#002 — 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 10, 1984

#003 — 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 23, 1988

#004 — 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 23, 1988