Details for New Drug Application (NDA): 020411
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The generic ingredient in CERVIDIL is dinoprostone. There is one drug master file entry 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 |
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 | 55566-2800-1 | 1 POUCH in 1 CARTON (55566-2800-1) / 10 mg in 1 POUCH (55566-2800-0) |
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 | ⤷ Start Trial | ⤷ Start Trial |
| Ferring Pharms Inc | CERVIDIL | dinoprostone | INSERT, EXTENDED RELEASE;VAGINAL | 020411-001 | Mar 30, 1995 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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