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Last Updated: December 6, 2019

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Details for New Drug Application (NDA): 019617

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NDA 019617 describes PREPIDIL, 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 PREPIDIL profile page.

The generic ingredient in PREPIDIL is dinoprostone. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dinoprostone profile page.
Summary for 019617
Applicant:Pharmacia And Upjohn
Formulation / Manufacturing:see details
Pharmacology for NDA: 019617
Medical Subject Heading (MeSH) Categories for 019617
Suppliers and Packaging for NDA: 019617
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREPIDIL dinoprostone GEL;ENDOCERVICAL 019617 NDA Pharmacia and Upjohn Company LLC 0009-3359 0009-3359-02 5 CARTON in 1 PACKAGE (0009-3359-02) > 1 SYRINGE in 1 CARTON (0009-3359-01) > 3 g in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;ENDOCERVICALStrength0.5MG/3GM
Approval Date:Dec 9, 1992TE:RLD:Yes

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