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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-one suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.

Summary for NDA: 018565

Tradename:
DURAMORPH PF
Applicant:
West-ward Pharms Int
Ingredient:
morphine sulfate
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 Pharmaceutical Corp. 0641-6019 0641-6019-10 10 AMPULE in 1 CARTON (0641-6019-10) > 10 mL in 1 AMPULE (0641-6019-01)
INFUMORPH
morphine sulfate
INJECTABLE;INJECTION 018565 NDA West-Ward Pharmaceutical Corp. 0641-6019 0641-6019-10 10 AMPULE in 1 CARTON (0641-6019-10) > 10 mL in 1 AMPULE (0641-6019-01)

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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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