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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 205386

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NDA 205386 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-eight 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 suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.

Summary for 205386

Tradename:	MORPHINE SULFATE
Applicant:	Dr Reddys Labs Sa
Ingredient:	morphine sulfate
Patents:	0

Pharmacology for NDA: 205386

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 205386

Analgesics, Opioid
Narcotics

Suppliers and Packaging for NDA: 205386

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MORPHINE SULFATE	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	205386	ANDA	Mayne Pharma Commercial LLC	51862-185	51862-185-01	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51862-185-01)
MORPHINE SULFATE	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	205386	ANDA	Mayne Pharma Commercial LLC	51862-186	51862-186-01	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51862-186-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	15MG
Approval Date:	Oct 28, 2016	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	30MG
Approval Date:	Oct 28, 2016	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	60MG
Approval Date:	Oct 28, 2016	TE:		RLD:	No

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