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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 NDA: 019617

Pharmacology for NDA: 019617


Suppliers and Packaging for NDA: 019617

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GEL;ENDOCERVICAL 019617 NDA Pharmacia and Upjohn Company 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

Summary for product number 001

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

Expired Orange Book Patents for NDA: 019617

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn
GEL;ENDOCERVICAL019617-001Dec 9, 19923,966,962► subscribe
Pharmacia And Upjohn
GEL;ENDOCERVICAL019617-001Dec 9, 19924,680,312► subscribe
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