Viewing data from:

INFUVITE PEDIATRIC

NDA

ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K | N021265 | 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 -44	View Letter (PDF)
Mar 21, 2016	SUPPL -30	View Letter (PDF)
Dec 23, 2008	SUPPL -15	View Letter (PDF)
Jun 7, 2004	SUPPL -5	View Letter (PDF)
Feb 21, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: Feb 21, 2001

No patent or exclusivity listings for this strength.

#002 — 80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS | Approved: Jan 29, 2004