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Last Updated: December 30, 2025

Details for New Drug Application (NDA): 078761

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NDA 078761 describes MORPHINE SULFATE, which is a drug marketed by Actavis Elizabeth, Anda Repository, Impax Labs Inc, Strides Pharma Intl, 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, Padagis Us, Pharm Assoc, Rhodes Pharms, Sankalp Lifecare, 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-six 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. Twenty-eight suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.

Summary for 078761

Tradename:	MORPHINE SULFATE
Applicant:	Sun Pharm Inds Ltd
Ingredient:	morphine sulfate
Patents:	0

Pharmacology for NDA: 078761

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 078761

Analgesics, Opioid
Narcotics

Suppliers and Packaging for NDA: 078761

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MORPHINE SULFATE	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	078761	ANDA	Sun Pharmaceutical Industries, Inc.	63304-450	63304-450-01	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-450-01)
MORPHINE SULFATE	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	078761	ANDA	Sun Pharmaceutical Industries, Inc.	63304-450	63304-450-03	10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-450-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	15MG
Approval Date:	May 11, 2012	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	30MG
Approval Date:	May 11, 2012	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	60MG
Approval Date:	May 11, 2012	TE:	AB	RLD:	No

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