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Details for New Drug Application (NDA): 020411
The generic ingredient in CERVIDIL 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 020411
Tradename: | CERVIDIL |
Applicant: | Ferring Pharms Inc |
Ingredient: | dinoprostone |
Patents: | 0 |
Therapeutic Class: | Hormonal Agents, Stimulant/Replacement/Modifying (Prostaglandins) |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020411
Ingredient-type | Prostaglandins |
Medical Subject Heading (MeSH) Categories for 020411
Suppliers and Packaging for NDA: 020411
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CERVIDIL | dinoprostone | INSERT, EXTENDED RELEASE;VAGINAL | 020411 | NDA | Ferring Pharmaceuticals Inc. | 55566-2800 | N | 55566-2800-1 |
CERVIDIL | dinoprostone | INSERT, EXTENDED RELEASE;VAGINAL | 020411 | NDA | Ferring Pharmaceuticals Inc. | 55566-9500 | N | 55566-9500-1 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INSERT, EXTENDED RELEASE;VAGINAL | Strength | 10MG | ||||
Approval Date: | Mar 30, 1995 | TE: | RLD: | Yes |
Expired US Patents for NDA 020411
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ferring Pharms Inc | CERVIDIL | dinoprostone | INSERT, EXTENDED RELEASE;VAGINAL | 020411-001 | Mar 30, 1995 | ➤ Sign Up | ➤ Sign Up |
Ferring Pharms Inc | CERVIDIL | dinoprostone | INSERT, EXTENDED RELEASE;VAGINAL | 020411-001 | Mar 30, 1995 | ➤ Sign Up | ➤ Sign Up |
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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