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PERSANTINE

NDA

DIPYRIDAMOLE | N012836 | BOEHRINGER INGELHEIM PHARMACEUTICALS INC

3 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 Chain8 active DMFs10 inactive

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

SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRLDIPYRIDAMOLE

DMF 32091978

AGC PHARMA CHEMICALS EUROPE SLUDIPYRIDAMOLE

DMF 138701998

ORCHID PHARMA LTDDIPYRIDAMOLE

DMF 204162007

MATRIX PHARMACORP PRIVATE LTDDIPYRIDAMOLE USP

DMF 244412010

ALIVUS LIFE SCIENCES LTDDIPYRIDAMOLE USP

DMF 290202015

COHANCE LIFESCIENCES LTDDIPYRIDAMOLE USP

DMF 297452015

QIDONG DONGYUE PHARMACEUTICAL CO LTDDIPYRIDAMOLE

DMF 349952020

SOLARA ACTIVE PHARMA SCIENCES LTDDIPYRIDAMOLE USP

DMF 350452020

ERREGIERRE SPAInactiveDIPYRIDAMOLE

DMF 34891979

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPAInactiveDIPYRIDAMOLE

DMF 35591979

SA AJINOMOTO OMNICHEM NVInactiveDIPYRIDAMOLE

DMF 38671980

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPAInactiveDIPYRIDAMOLE

DMF 40161980

SHANGHAI NO 6 PHARMACEUTICAL FACTORYInactiveDIPYRIDAMOLE

DMF 59171985

MEDICHEM SAInactiveDIPYRIDAMOLE

DMF 63171986

LISAC SAInactiveDIPYRIDAMOLE

DMF 79051989

OMNICHEM NVInactiveDIPYRIDAMOLE USP

DMF 148862000

BOEHRINGER INGELHEIM LABSO CHIMIE FINEInactiveDIPYRIDAMOLE

DMF 227642009

YABAO PHARMACEUTICAL GROUP CO LTDInactiveDIPYRIDAMOLE USP

DMF 285662014

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Dec 12, 2019	SUPPL -61	View Letter (PDF)
Aug 3, 2005	SUPPL -57	View Letter (PDF)
Aug 6, 2004	SUPPL -54	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#003 — 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 22, 1986

No patent or exclusivity listings for this strength.

#004 — 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 6, 1987

#005 — 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 6, 1987