Orange Book product
MONOKET 20MG
Orange Book NDA 020215 · OMNIVIUM PHARMACEUTICALS LLC · Prescription
Key facts
| Proprietary name | MONOKET |
|---|---|
| Active ingredients | ISOSORBIDE MONONITRATE |
| Strength | 20MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | NDA020215 |
| Applicant holder | OMNIVIUM PHARMACEUTICALS LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | Yes |
| Approval date | Jun 30, 1993 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- Yes Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.