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US Army
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Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204053

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NDA 204053 describes MORPHINE SULFATE, which is a drug marketed by Actavis Elizabeth, Impax Labs Inc, Par Pharm Inc, Teva Pharms Usa, Upsher-smith Labs, Eurohlth Intl Sarl, Hospira, Hospira Inc, Icu Medical Inc, Meridian Medcl Techn, Specgx Llc, Watson Labs, Fresenius Kabi Usa, Ani Pharms Inc, Hi-tech Pharmacal, Lannett Co Inc, Nostrum Labs Inc, Paddock Llc, Pharm Assoc, Rhodes Pharms, Tris Pharma Inc, Vintage Pharms Llc, Vistapharm, West-ward Pharms Int, Dava Pharms Inc, Epic Pharma Llc, Mayne Pharma Inc, Mylan Pharms Inc, Nesher Pharms, Novel Labs Inc, Sun Pharm Inds Ltd, and Sun Pharm Industries, and is included in fifty-four NDAs. It is available from forty-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. Fifty-four suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.
Summary for 204053
Tradename:MORPHINE SULFATE
Applicant:Nostrum Labs Inc
Ingredient:morphine sulfate
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 204053
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 204053
Suppliers and Packaging for NDA: 204053
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MORPHINE SULFATE morphine sulfate SOLUTION;ORAL 204053 ANDA Nostrum Laboratories, Inc. 70408-746 N 70408-746-29
MORPHINE SULFATE morphine sulfate SOLUTION;ORAL 204053 ANDA Nostrum Laboratories, Inc. 70408-746 N 70408-746-31

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength100MG/5ML
Approval Date:Oct 6, 2016TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
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Boehringer Ingelheim
Johnson and Johnson
US Army
Julphar
Colorcon
Medtronic
Cipla

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