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M.V.I.-12 ADULT

NDA

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E | N008809 | HOSPIRA INC

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Nov 13, 2017	SUPPL -73	View Letter (PDF)
Mar 28, 2013	SUPPL -66	View Letter (PDF)
Jun 15, 2012	SUPPL -65	View Letter (PDF)
Sep 10, 2004	SUPPL -54	View Letter (PDF)
Apr 29, 2004	SUPPL -52	View Letter (PDF)
Jun 4, 2002	SUPPL -46	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#004 — 10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;20 IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/ML;0.3MG/ML;330 UNITS/ML;1 IU/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Aug 8, 1985

No patent or exclusivity listings for this strength.

#005 — 20MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;20 IU/ML;0.6MG/ML;4MG/ML;0.4MG/ML;0.36MG/ML;0.6MG/ML;330 UNITS/ML;1 IU/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Apr 22, 2004

#006 — 20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Sep 9, 2004