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LEVOPHED

NDA

NOREPINEPHRINE BITARTRATE | N007513 | HOSPIRA INC

1 strength0 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 Chain4 active DMFs1 inactive

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

CHEMPACIFIC CORPNOREPINEPHRINE BITARTRATE

DMF 163442002

HARMAN FINOCHEM LTDNOREPINEPHRINE BITARTRATE USP

DMF 331272018

SUN PHARMACEUTICAL INDUSTRIES LTDNOREPINEPHRINE BITARTRATE USP

DMF 351842021

ZHEJIANG BOXIAO BIOPHARMACEUTICAL CO LTDNOREPINEPHRINE BITARTRATE (NON-STERILE, ACTIVE PHARMACEUTICAL INGREDIENT)

DMF 400172024

WUHAN WUYAO PHARMACEUTICAL CO LTDInactiveNOREPINEPHRINE BITARTRATE USP, NON-STERILE, BULK DRUG

DMF 153672001

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

Approval Letters

3 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 1MG BASE/ML

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.