Application 020379
- Type
- NDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CAVERJECT | ALPROSTADIL | INJECTABLE;INJECTION | 0.01MG/VIAL | Yes | No |
| 002 | CAVERJECT | ALPROSTADIL | INJECTABLE;INJECTION | 0.02MG/VIAL | Yes | Yes |
| 003 | CAVERJECT | ALPROSTADIL | INJECTABLE;INJECTION | 0.005MG/VIAL | Yes | No |
| 004 | CAVERJECT | ALPROSTADIL | INJECTABLE;INJECTION | 0.04MG/VIAL | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0009-3701 | Caverject | Alprostadil | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-7686 | Caverject | Alprostadil | Pharmacia and Upjohn Company LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 73050 | SUPPL | 2022-12-27 |
| 73038 | SUPPL | 2022-12-27 |
| 50643 | SUPPL | 2017-12-07 |
| 50642 | SUPPL | 2017-12-07 |
| 50635 | SUPPL | 2017-12-07 |
| 50634 | SUPPL | 2017-12-07 |
| 50633 | SUPPL | 2017-12-07 |
| 50632 | SUPPL | 2017-12-07 |
| 12502 | SUPPL | 2016-05-06 |
| 2426 | SUPPL | 2016-05-06 |
| 34574 | SUPPL | 2014-06-17 |
| 24870 | SUPPL | 2014-06-17 |
| 2425 | SUPPL | 2003-09-09 |
| 2424 | SUPPL | 2002-01-15 |
| 20619 | SUPPL | 1998-03-26 |