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AMINOSYN II 10% W/ ELECTROLYTES

NDA

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE | N019437 | ICU MEDICAL INC

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
May 27, 2004	SUPPL -15	View Letter (PDF)
Jul 6, 2003	SUPPL -14	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#004 — 10%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Apr 3, 1986

No patent or exclusivity listings for this strength.

#007 — 3.5%;30MG/100ML;97MG/100ML;120MG/100ML;49MG/100ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Apr 3, 1986

#006 — 7%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Apr 3, 1986

#005 — 8.5%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Apr 3, 1986

#008 — 8.5%;102MG/100ML;492MG/100ML;60MG/100ML;425MG/100ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 25, 2002