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DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER

NDA

DOPAMINE HYDROCHLORIDE | N019099 | B BRAUN MEDICAL INC

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 Chain1 active DMF1 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBHDOPAMINE HYDROCHLORIDE

DMF 31161977

WINTHROP PHARMACEUTICALS DIV STERLING DRUG INCInactiveDOPAMINE HYDROCHLORIDE

DMF 24531975

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 11, 2005	SUPPL -8	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#002 — 80MG/100ML

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 15, 1986

#004 — 320MG/100ML

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 15, 1986

#001 — 40MG/100ML

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Oct 15, 1986

No patent or exclusivity listings for this strength.

#003 — 160MG/100ML

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 15, 1986