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Generated: August 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018565

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NDA 018565 describes INFUMORPH, which is a drug marketed by West-ward Pharms Int and is included in one NDA. It is available from one supplier. Additional details are available on the INFUMORPH profile page.

The generic ingredient in INFUMORPH 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: 018565

Tradename:
2
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 018565

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 018565

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DURAMORPH PF
morphine sulfate
INJECTABLE;INJECTION 018565 NDA West-Ward Pharmaceuticals Corp. 0641-6019 0641-6019-10 10 AMPULE in 1 CARTON (0641-6019-10) > 10 mL in 1 AMPULE (0641-6019-01)
DURAMORPH PF
morphine sulfate
INJECTABLE;INJECTION 018565 NDA West-Ward Pharmaceuticals Corp. 0641-6020 0641-6020-10 10 AMPULE in 1 CARTON (0641-6020-10) > 10 mL in 1 AMPULE (0641-6020-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.5MG/ML
Approval Date:Sep 18, 1984TE:APRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Sep 18, 1984TE:APRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Jul 19, 1991TE:RLD:Yes


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