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DYNACIRC

NDA

ISRADIPINE | N019546 | SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE

2 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 Chain4 active DMFs3 inactive

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

STERLING WISCONSIN LLCISRADIPINE (FP-043)

DMF 168122003

QUIMICA SINTETICA SAISRADIPINE

DMF 173672004

YANGZHOU PHARMACEUTICAL CO LTDISRADIPINE (USP26)

DMF 173842004

CHEMOSWED ABISRADIPINE

DMF 193762006

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveISRADIPINE UPS

DMF 178732004

CHEMWERTH INCInactiveISRADIPINE USP, NON-STERILE BULK DRUG SUBSTANCE

DMF 207492007

SAI ADVANTIUM PHARMA LTDInactiveIsradipine USP

DMF 210132007

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 20, 2005	SUPPL -31	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Dec 20, 1990

No patent or exclusivity listings for this strength.

#002 — 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 20, 1990