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Generated: June 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203849

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NDA 203849 describes MORPHINE SULFATE, which is a drug marketed by Novel Labs Inc, Upsher Smith, Dava Pharms Inc, West-ward Pharms Int, Hospira, Vintage Pharms Llc, Impax Labs Inc, Nostrum Labs Inc, Par Pharm Inc, Mallinckrodt, Hospira Inc, Icu Medical Inc, Lannett Holdings Inc, Teva Pharms Usa, Tris Pharma Inc, Rhodes Pharms, Nesher Pharms, Fresenius Kabi Usa, Mylan Pharms Inc, Mallinckrodt Inc, Sun Pharm Inds, Actavis Elizabeth, Vistapharm, Watson Labs, Epic Pharma Llc, Eurohlth Intl Sarl, Sun Pharm Inds Ltd, Pharm Assoc, Paddock Llc, Mayne Pharma Inc, and Meridian Medcl Techn, and is included in fifty-one NDAs. It is available from forty-seven 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. Fifty-four suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.

Summary for NDA: 203849

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 203849

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 203849

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MORPHINE SULFATE
morphine sulfate
TABLET, EXTENDED RELEASE;ORAL 203849 ANDA Actavis Pharma, Inc. 0228-4270 0228-4270-11 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-4270-11)
MORPHINE SULFATE
morphine sulfate
TABLET, EXTENDED RELEASE;ORAL 203849 ANDA Actavis Pharma, Inc. 0228-4270 0228-4270-50 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-4270-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength15MG
Approval Date:Apr 6, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Apr 6, 2015TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Apr 6, 2015TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Medtronic
Colorcon
Johnson and Johnson
McKinsey
Moodys
Julphar
Novartis
Daiichi Sankyo
Merck
UBS

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