Application 019617
- Type
- NDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PREPIDIL | DINOPROSTONE | GEL;ENDOCERVICAL | 0.5MG/3GM | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0009-3359 | Prepidil | dinoprostone | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-3359 | Prepidil | dinoprostone | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-3359 | Prepidil | dinoprostone | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-3359 | Prepidil | dinoprostone | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-3359 | Prepidil | dinoprostone | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-3359 | Prepidil | dinoprostone | Pharmacia and Upjohn Company LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 48919 | SUPPL | 2017-07-06 |
| 48916 | SUPPL | 2017-07-06 |
| 1420 | SUPPL | 2010-02-22 |
| 11564 | SUPPL | 2010-02-16 |