Application 020649
- Type
- NDA
- Sponsor
- AUXILIUM PHARMS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | EDEX | ALPROSTADIL | INJECTABLE;INJECTION | 0.005MG/VIAL | No | No |
| 002 | EDEX | ALPROSTADIL | INJECTABLE;INJECTION | 0.01MG/VIAL | Yes | No |
| 003 | EDEX | ALPROSTADIL | INJECTABLE;INJECTION | 0.02MG/VIAL | Yes | No |
| 004 | EDEX | ALPROSTADIL | INJECTABLE;INJECTION | 0.04MG/VIAL | Yes | Yes |
| 005 | EDEX | ALPROSTADIL | INJECTABLE;INJECTION | 0.01MG/VIAL | Yes | Yes |
| 006 | EDEX | ALPROSTADIL | INJECTABLE;INJECTION | 0.02MG/VIAL | Yes | Yes |
| 007 | EDEX | 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 |
|---|
| 52244-010 | Edex | alprostadil | Endo Pharmaceuticals, Inc. | NDA | Current |
| 52244-010 | Edex | alprostadil | Endo Pharmaceuticals Inc. | NDA | Current |
| 52244-020 | Edex | alprostadil | Endo Pharmaceuticals, Inc. | NDA | Current |
| 52244-020 | Edex | alprostadil | Endo Pharmaceuticals Inc. | NDA | Current |
| 52244-040 | Edex | alprostadil | Endo Pharmaceuticals, Inc. | NDA | Current |
| 52244-040 | Edex | alprostadil | Endo Pharmaceuticals Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 35077 | SUPPL | 2015-03-26 |
| 25444 | SUPPL | 2015-03-11 |
| 25443 | SUPPL | 2006-06-12 |
| 12922 | SUPPL | 2006-06-12 |
| 41522 | ORIG | 2003-08-08 |