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Details for New Drug Application (NDA): 019617
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
Tradename: | PREPIDIL |
Applicant: | Pharmacia And Upjohn |
Ingredient: | dinoprostone |
Patents: | 0 |
Therapeutic Class: | Hormonal Agents, Stimulant/Replacement/Modifying (Prostaglandins) |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 019617
Ingredient-type | Prostaglandins |
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 | N | 0009-3359-02 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;ENDOCERVICAL | Strength | 0.5MG/3GM | ||||
Approval Date: | Dec 9, 1992 | TE: | RLD: | Yes |
Expired US Patents for NDA 019617
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pharmacia And Upjohn | PREPIDIL | dinoprostone | GEL;ENDOCERVICAL | 019617-001 | Dec 9, 1992 | ➤ Try a Free Trial | ➤ Try a Free Trial |
Pharmacia And Upjohn | PREPIDIL | dinoprostone | GEL;ENDOCERVICAL | 019617-001 | Dec 9, 1992 | ➤ Try a Free Trial | ➤ Try a Free Trial |
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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