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Generated: September 23, 2018

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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-three suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.
Summary for 018565
Tradename:INFUMORPH
Applicant:West-ward Pharms Int
Ingredient:morphine sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018565
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 018565
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)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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