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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 202861

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NDA 202861 describes MORPHINE SULFATE, which is a drug marketed by Actavis Elizabeth, Impax Labs Inc, Nortec Dev Assoc, Strides Pharma, Teva Pharms Usa, Upsher Smith Labs, Hikma, Hospira, Hospira Inc, Icu Medical Inc, Intl Medication Sys, Specgx Llc, Watson Labs, Fresenius Kabi Usa, Ani Pharms, Chartwell Molecular, Nostrum Labs Inc, Padagis Us, Pharm Assoc, Rhodes Pharms, Tris Pharma Inc, Vistapharm, Winder Labs Llc, Dava Pharms Inc, Dr Reddys Labs Sa, Epic Pharma Llc, Nesher Pharms, Novel Labs Inc, Rising, Sun Pharm Inds Ltd, Sun Pharm Industries, Alkem Labs Ltd, Ingenus Pharms Nj, and Meridian Medcl Techn, and is included in sixty-two NDAs. It is available from twenty-nine suppliers. There are three patents protecting this drug. Additional details are available on the MORPHINE SULFATE profile page.

The generic ingredient in MORPHINE SULFATE is morphine sulfate. There are twenty-three drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.

Summary for 202861

Tradename:	MORPHINE SULFATE
Applicant:	Intl Medication Sys
Ingredient:	morphine sulfate
Patents:	0

Pharmacology for NDA: 202861

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 202861

Analgesics, Opioid
Narcotics

Suppliers and Packaging for NDA: 202861

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MORPHINE SULFATE	morphine sulfate	INJECTABLE;INJECTION	202861	ANDA	International Medication Systems, Limited	76329-1912	76329-1912-1	1 VIAL in 1 CARTON (76329-1912-1) / 30 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/ML
Approval Date:	Apr 29, 2021	TE:		RLD:	No

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