Enalapril Oral Solution
- Brand(s)
- Epaned
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Silvergate Pharmaceuticals, Inc. (2015-01-12)
- Oldest Current Product
- 2013-08-22
- License(s)
- NDA
- RxNORM
- ORAL SOLUTION\ENALAPRIL
- FDAOB
- ORAL\FOR SOLUTION\ENALAPRIL MALEATE
- SPL Active
- ORAL\POWDER, FOR SOLUTION\ENALAPRIL MALEATE
- SPL Moiety
- ORAL\POWDER, FOR SOLUTION\ENALAPRILAT ANHYDROUS
product(s) by strength(s)
enalapril maleate 1 mg/ml oral solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 526521001 | Epaned | NDA | Silvergate Pharmaceuticals, Inc. | 2013-08-22 | ENALAPRIL MALEATE | ORAL | POWDER, FOR SOLUTION | NDA204308 | 94c9a9d6-957f-4667-8f09-509e99bac777 |
application(s)
| # | id | title | applicant | approved | patent | approved drug |
|---|---|---|---|---|---|---|
| 1 | NDA204308 | EPANED KIT | SILVERGATE PHARMACEUTICALS INC | 2013-08-13 | p8778366, METHOD OF TREATING HYPERTENSION/ TREATMENT OF HYPERTENSION p8568747, SUBSTANCE | NDA204308_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA204308_001 | RX | ENALAPRIL MALEATE (1MG/ML) | ORAL | FOR SOLUTION | True | 2013-08-13 | EPANED KIT |
patent(s)
| # | id | expiration date | application(s) |
|---|---|---|---|
| 1 | p8568747 (view patent) | 2032-11-06 | NDA204308 |
| 2 | p8778366 (view patent) | 2032-11-06 | NDA204308 |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 94c9a9d6-957f-4667-8f09-509e99bac777 (view SPL) | These highlights do not include all the information needed to use EPANED safely and effectively. See full prescribing information for EPANED. EPANED (enalapril) for Oral SolutionInitial U.S. Approval: 1985 | prescription | Human Prescription | Silvergate Pharmaceuticals, Inc. | ANALYSIS, API MANUFACTURE, MANUFACTURE | 2015-01-12 | 3 | 526521001 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII