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Details for New Drug Application (NDA): 075295

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NDA 075295 describes MORPHINE SULFATE, which is a drug marketed by Novel Labs Inc, Upsher Smith, Dava Pharms Inc, Roxane, Hospira, Vintage Pharms Llc, Impax Labs Inc, Nostrum Labs Inc, Par Pharm Inc, Mallinckrodt, Hospira Inc, Lannett Holdings Inc, Teva Pharms Usa, Tris Pharma Inc, Rhodes Pharms, Nesher Pharms, Fresenius Kabi Usa, Mylan Pharms Inc, Sun Pharm Inds Ltd, Actavis Elizabeth, Vistapharm, Mallinckrodt Inc, Watson Labs, Corepharma, Eurohlth Intl Sarl, Pharm Assoc, Paddock Llc, Mayne Pharma Inc, and Meridian Medcl Techn, and is included in fifty-one NDAs. It is available from forty-three 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-one suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.

Summary for NDA: 075295

Tradename:
MORPHINE SULFATE
Applicant:
Vintage Pharms Llc
Ingredient:
morphine sulfate
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 075295

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 075295

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MORPHINE SULFATE
morphine sulfate
TABLET, EXTENDED RELEASE;ORAL 075295 ANDA Lake Erie Medical DBA Quality Care Products LLC 49999-845 49999-845-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49999-845-30)
MORPHINE SULFATE
morphine sulfate
TABLET, EXTENDED RELEASE;ORAL 075295 ANDA Lake Erie Medical DBA Quality Care Products LLC 49999-845 49999-845-01 120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49999-845-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength15MG
Approval Date:Oct 28, 1998TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Oct 28, 1998TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Oct 28, 1998TE:ABRLD:No


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