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NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

ANDA

NOREPINEPHRINE BITARTRATE | A220483 | SAGENT PHARMACEUTICALS

1 strength0 unique patents0 unique exclusivities

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

1 letter from Drugs@FDA

Date	Submission	Document
Jun 8, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Mar 26, 2026

No patent or exclusivity listings for this strength.