Application 018484
- Type
- NDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PROSTIN VR PEDIATRIC | ALPROSTADIL | INJECTABLE;INJECTION | 0.5MG/ML | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0009-0215 | PROSTIN | alprostadil | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-3169 | PROSTIN | alprostadil | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-3169 | PROSTIN | alprostadil | Pharmacia and Upjohn Company LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84647 | SUPPL | 2026-01-06 |
| 84529 | SUPPL | 2025-12-23 |
| 60546 | SUPPL | 2019-10-11 |
| 59382 | SUPPL | 2019-07-19 |