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DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

NDA

DOBUTAMINE HYDROCHLORIDE | N020255 | BAXTER HEALTHCARE CORP

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain5 active DMFs7 inactive

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

CHEMWERTH INCDOBUTAMINE HYDROCHLORIDE

DMF 88561990

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPADOBUTAMINE HYDROCHLORIDE

DMF 97621992

SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBHDOBUTAMINE HYDROCHLORIDE

DMF 110231994

HAINAN POLY PHARM CO LTDDOBUTAMINE HYDROCHLORIDE USP

DMF 352172020

ARAGEN LIFE SCIENCES LTDDOBUTAMINE HYDROCHLORIDE

DMF 426022025

ABBOTT LABORATORIESInactiveDOBUTAMINE HYDROCHLORIDE

DMF 85891990

RAYLO CHEMICALSInactiveDOBUTAMINE HYDROCHLORIDE

DMF 90241991

SUMIKA FINE CHEMICALS CO LTDInactiveDOBUTAMINE HYDROCHLORIDE

DMF 93691991

HUHTAMAKI OY LEIRAS PHARMACEUTICALSInactiveDOBUTAMINE HYDROCHLORIDE

DMF 98881992

EGIS PHARMACEUTICALS PRIVATE LTDInactiveDOBUTAMINE HYDROCHLORIDE

DMF 100971993

CHEMSYN SCIENCE LABORATORIESInactiveDOBUTAMINE HYDROCHLORIDE

DMF 102961993

IROTEC LABORATORIESInactiveDOBUTAMINE HYDROCHLORIDE

DMF 107061994

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Sep 11, 2023	SUPPL -25	View Letter (PDF)
Feb 3, 2021	SUPPL -22	View Letter (PDF)
Mar 28, 2019	SUPPL -20	View Letter (PDF)
Apr 23, 2013	SUPPL -16	View Letter (PDF)
Mar 12, 2012	SUPPL -14	View Letter (PDF)
Jul 28, 2003	SUPPL -9	View Letter (PDF)
Jul 28, 2003	SUPPL -11	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 50MG BASE/100ML

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Oct 19, 1993

No patent or exclusivity listings for this strength.

#003 — EQ 100MG BASE/100ML

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 19, 1993

#004 — EQ 200MG BASE/100ML

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 19, 1993

#005 — EQ 400MG BASE/100ML

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 19, 1993