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NDA

ISOPROTERENOL HYDROCHLORIDE | N010515 | BAUSCH HEALTH US LLC

1 strength0 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 Chain11 active DMFs4 inactive

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

HOSPIRA INCISOPROTERENOL HYDROCHLORIDE DRUG SUBSTANCE

DMF 252122011

STERLING WISCONSIN LLCISOPROTERENOL HYDROCHLORIDE USP

DMF 274692013

MICRO LABS LTDISOPROTERENOL HYDROCHLORIDE USP

DMF 297322015

AMPHASTAR NANJING PHARMACEUTICALS INCISOPROTERENOL HYDROCHLORIDE USP

DMF 298762015

HARMAN FINOCHEM LTDISOPROTERENOL HYDROCHLORIDE USP

DMF 307072016

BIOPHORE INDIA PHARMACEUTICALS PVT LTDISOPROTERENOL HYDROCHLORIDE

DMF 308112016

EDMOND PHARMA SRLISOPROTERENOL HYDROCHLORIDE

DMF 315692017

APITORIA PHARMA PRIVATE LTDISOPROTERENOL HYDROCHLORIDE

DMF 319302017

EMCURE PHARMACEUTICALS LTDISOPROTERENOL HYDROCHLORIDE USP

DMF 321512017

GLAND PHARMA LTDISOPROTERENOL HYDROCHLORIDE

DMF 334452019

DEVA HOLDING ASISOPROTERENOL HYDROCHLORIDE USP

DMF 366342022

SUMIKA FINE CHEMICALS CO LTDInactiveISOPROTERENOL HYDROCHLORIDE USP XX

DMF 51321983

BOEHRINGER INGELHEIM PHARMA KGInactiveISOPROTERENOL HYDROCHLORIDE

DMF 89011990

SAI LIFE SCIENCES LTDInactiveISOPROTERENOL HYDROCHLORIDE USP

DMF 297172015

SUNNY PHARMTECH INCInactiveISOPROTERENOL HYDROCHLORIDE USP

DMF 319272018

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Oct 21, 2022	SUPPL -33	View Letter (PDF)
May 4, 1999	SUPPL -22	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

No patent or exclusivity listings for this strength.