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Generated: November 20, 2018

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Details for New Drug Application (NDA): 018484

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NDA 018484 describes PROSTIN VR PEDIATRIC, which is a drug marketed by Pharmacia And Upjohn and is included in one NDA. It is available from one supplier. Additional details are available on the PROSTIN VR PEDIATRIC profile page.

The generic ingredient in PROSTIN VR PEDIATRIC is alprostadil. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the alprostadil profile page.
Summary for 018484
Tradename:PROSTIN VR PEDIATRIC
Applicant:Pharmacia And Upjohn
Ingredient:alprostadil
Patents:0
Pharmacology for NDA: 018484
Medical Subject Heading (MeSH) Categories for 018484
Suppliers and Packaging for NDA: 018484
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROSTIN VR PEDIATRIC alprostadil INJECTABLE;INJECTION 018484 NDA Pharmacia and Upjohn Company LLC 0009-3169 0009-3169-06 5 AMPULE in 1 PACKAGE (0009-3169-06) > 1 mL in 1 AMPULE (0009-3169-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.5MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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