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Generated: September 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204223

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NDA 204223 describes MORPHINE SULFATE, which is a drug marketed by Novel Labs Inc, Upsher-smith Labs, Dava Pharms Inc, West-ward Pharms Int, Rhodes Pharms, Hospira, Hi-tech Pharmacal, 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, 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-three 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: 204223

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:3
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 204223

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 204223

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MORPHINE SULFATE
morphine sulfate
SOLUTION;INTRAMUSCULAR, INTRAVENOUS 204223 NDA Fresenius Kabi, USA LLC 76045-004 76045-004-10 24 BLISTER PACK in 1 CARTON (76045-004-10) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS
MORPHINE SULFATE
morphine sulfate
SOLUTION;INTRAMUSCULAR, INTRAVENOUS 204223 NDA Fresenius Kabi, USA LLC 76045-005 76045-005-10 24 BLISTER PACK in 1 CARTON (76045-005-10) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULAR, INTRAVENOUSStrength2MG/ML (2MG/ML)
Approval Date:Oct 30, 2013TE:RLD:Yes
Patent:► SubscribePatent Expiration:Mar 12, 2034Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Mar 12, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF CHRONIC PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
Patent:► SubscribePatent Expiration:Mar 12, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PAIN


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Serving 500+ biopharmaceutical companies globally:

Healthtrust
US Army
Teva
Express Scripts
Boehringer Ingelheim
QuintilesIMS
Cipla
Colorcon
Farmers Insurance
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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