Viewing data from:

MANNITOL 5%

NDA

MANNITOL | N016269 | HOSPIRA INC

6 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 Chain3 active DMFs4 inactive

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

ROQUETTE FRERESMANNITOL USP GRADE (PEARLITOL PF)

DMF 128791998

SHANDONG TIANLI PHARMACEUTICAL CO LTDMANNITOL

DMF 390352023

AUTHENTERRA HEALTHCARE LLPMANNITOL IP/BP/EP/USP

DMF 426002025

ROQUETTE FRERESInactiveMANNITOL

DMF 54431984

SAN FU CHEMICAL CO LTDInactiveMANNITOL

DMF 61991985

ROQUETTE FRERESInactiveMANNITOL GRANULAR G.G.

DMF 66501986

CORN PRODUCTS BRASIL INGREDIENTS INDUSTRIAIS LTDAInactiveMANNITOL

DMF 72461987

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Mar 19, 2020	SUPPL -56	View Letter (PDF)
Jan 23, 2019	SUPPL -55	View Letter (PDF)

Source: Drugs@FDA application documents.