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TRAVASOL 5.5% IN PLASTIC CONTAINER

NDA

AMINO ACIDS | N018931 | BAXTER HEALTHCARE CORP

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 Chain4 active DMFs4 inactive

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

KYOWA HAKKO BIO CO LTDAMINO ACIDS

DMF 31311978

KYOWA HAKKO BIO CO LTDAMINO ACIDS

DMF 31491978

AJINOMOTO HEALTH AND NUTRITION NORTH AMERICA INCAMINO ACIDS

DMF 45551982

SHANGHAI PLUMINO AMINO ACID CO LTDAMINO ACIDS

DMF 320882017

BOOTS FLINT INC SUB BOOTS CO USA INCInactiveAMINO ACIDS

DMF 281946

KYOWA HAKKO KOGYO CO LTDInactiveAMINO ACIDS

DMF 26311976

SIGMA F AND D DIV LTDInactiveAMINO ACIDS & THEIR SODIUM SALT DERIVATIVES RELATIVE TO HFN-130 INDs

DMF 26611976

NIPPON RIKAGAKUYAKUHIN CO LTDInactiveAMINO ACIDS

DMF 58961985

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Sep 24, 2020	SUPPL -55	View Letter (PDF)
Nov 17, 2017	SUPPL -49	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#003 — 10% (10MG/100ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Aug 23, 1984

#001 — 5.5% (5.5GM/100ML)

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Aug 23, 1984

No patent or exclusivity listings for this strength.

#002 — 8.5% (8.5GM/100ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Aug 23, 1984