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INFUVITE ADULT

NDA

ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K | N021163 | SANDOZ CANADA INC

2 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

5 letters from Drugs@FDA

Date	Submission	Document
Nov 7, 2024	SUPPL -45	View Letter (PDF)
Dec 11, 2008	SUPPL -16	View Letter (PDF)
Sep 17, 2004	SUPPL -11	View Letter (PDF)
Jun 7, 2004	SUPPL -5	View Letter (PDF)
May 18, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML

RLDAP

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: May 18, 2000

No patent or exclusivity listings for this strength.

#002 — 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML

RLDAP

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Jun 16, 2003