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PRONESTYL

NDA

PROCAINAMIDE HYDROCHLORIDE | N007335 | APOTHECON INC DIV BRISTOL MYERS SQUIBB

5 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 DMFs1 inactive

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

W R GRACE AND CO -CONNPROCAINAMIDE HYDROCHLORIDE

DMF 49111983

CHENG FONG CHEMICAL CO LTDPROCAINAMIDE HYDROCHLORIDE USP

DMF 254612011

BIOPHORE INDIA PHARMACEUTICALS PVT LTDPROCAINAMIDE HYDROCHLORIDE USP

DMF 332162018

GLAND PHARMA LTDPROCAINAMIDE HYDROCHLORIDE

DMF 364022021

GANES CHEMICALS INC PENNSVILLE DIVInactivePROCAINAMIDE HYDROCHLORIDE

DMF 21331973

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

Products (5)

Sort:

#001 — 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#003 — 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

#004 — 375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

#005 — 500MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982