Details for New Drug Application (NDA): 211382

NDA 211382 describes NOREPINEPHRINE BITARTRATE, which is a drug marketed by Amneal, Anthea Pharma, Aspiro, Baxter Hlthcare Corp, Biocon Pharma, Breckenridge, Caplin, Fresenius Kabi Usa, Gland, Hikma, Meitheal, Metrics Pharm, MSN, Mylan Labs Ltd, Nephron, Rising, Sandoz, Sun Pharm, Zydus Pharms, Inforlife, Long Grove Pharms, and Sagent, and is included in twenty-five NDAs. It is available from twenty-two suppliers. There are twelve patents protecting this drug. Additional details are available on the NOREPINEPHRINE BITARTRATE profile page.

The generic ingredient in NOREPINEPHRINE BITARTRATE is norepinephrine bitartrate. There are five drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the norepinephrine bitartrate profile page.

Summary for 211382

Tradename:	NOREPINEPHRINE BITARTRATE
Applicant:	Fresenius Kabi Usa
Ingredient:	norepinephrine bitartrate
Patents:	0

Pharmacology for NDA: 211382

Medical Subject Heading (MeSH) Categories for 211382

Adrenergic alpha-Agonists

Sympathomimetics

Vasoconstrictor Agents

Suppliers and Packaging for NDA: 211382

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	INJECTABLE;INJECTION	211382	ANDA	Fresenius Kabi USA, LLC	63323-940	63323-940-04	10 VIAL, SINGLE-DOSE in 1 CARTON (63323-940-04) / 4 mL in 1 VIAL, SINGLE-DOSE (63323-940-21)
NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	INJECTABLE;INJECTION	211382	ANDA	Fresenius Kabi USA, LLC	65219-140	65219-140-04	10 VIAL, SINGLE-DOSE in 1 CARTON (65219-140-04) / 4 mL in 1 VIAL, SINGLE-DOSE (65219-140-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1MG BASE/ML
Approval Date:	Nov 3, 2020	TE:	AP	RLD:	No

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