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Last Updated: November 19, 2019

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Details for New Drug Application (NDA): 017810

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NDA 017810 describes PROSTIN E2, 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 E2 profile page.

The generic ingredient in PROSTIN E2 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 017810
Tradename:PROSTIN E2
Applicant:Pharmacia And Upjohn
Ingredient:dinoprostone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 017810
Medical Subject Heading (MeSH) Categories for 017810
Suppliers and Packaging for NDA: 017810
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROSTIN E2 dinoprostone SUPPOSITORY;VAGINAL 017810 NDA Pharmacia and Upjohn Company LLC 0009-0827 0009-0827-03 5 BLISTER PACK in 1 CARTON (0009-0827-03) > 1 SUPPOSITORY in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUPPOSITORY;VAGINALStrength20MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Expired US Patents for NDA 017810

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn PROSTIN E2 dinoprostone SUPPOSITORY;VAGINAL 017810-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Pharmacia And Upjohn PROSTIN E2 dinoprostone SUPPOSITORY;VAGINAL 017810-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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