Application 204308
- Type
- NDA
- Sponsor
- SILVERGATE PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EPANED KIT | ENALAPRIL MALEATE | FOR SOLUTION;ORAL | 1MG/ML | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 52652-1001 | EPANED | enalapril maleate | Silvergate Pharmaceuticals, Inc. | NDA | Current |
| 52652-1001 | EPANED | enalapril maleate | Silvergate Pharmaceuticals, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 49184 | SUPPL | 2017-08-02 |
| 49152 | SUPPL | 2017-07-31 |
| 47679 | SUPPL | 2017-03-24 |
| 47655 | SUPPL | 2017-03-23 |
| 40374 | SUPPL | 2016-02-02 |
| 10321 | SUPPL | 2016-01-29 |
| 19544 | SUPPL | 2014-09-09 |
| 19543 | SUPPL | 2014-09-09 |
| 32542 | SUPPL | 2014-09-08 |
| 10320 | SUPPL | 2014-09-08 |
| 24466 | ORIG | 2014-06-27 |
| 22951 | ORIG | 2014-06-27 |
| 40373 | ORIG | 2013-08-15 |
| 10319 | ORIG | 2013-08-15 |