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Generated: August 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205758

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NDA 205758 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: 205758

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 205758

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 205758

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MORPHINE SULFATE
morphine sulfate
INJECTABLE;INJECTION 205758 ANDA West-Ward Pharmaceuticals Corp. 0641-6125 0641-6125-25 25 VIAL, SINGLE-DOSE in 1 PACKAGE (0641-6125-25) > 1 mL in 1 VIAL, SINGLE-DOSE (0641-6125-01)
MORPHINE SULFATE
morphine sulfate
INJECTABLE;INJECTION 205758 ANDA West-Ward Pharmaceuticals Corp. 0641-6126 0641-6126-25 25 VIAL, SINGLE-DOSE in 1 PACKAGE (0641-6126-25) > 1 mL in 1 VIAL, SINGLE-DOSE (0641-6126-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength4MG/ML
Approval Date:May 21, 2015TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength8MG/ML
Approval Date:May 21, 2015TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:May 21, 2015TE:APRLD:No


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