Orange Book product
ISOSORBIDE DINITRATE 40MG
Orange Book ANDA 213057 · ZYDUS LIFESCIENCES GLOBAL FZE · Prescription
Key facts
| Proprietary name | ISOSORBIDE DINITRATE |
|---|---|
| Active ingredients | ISOSORBIDE DINITRATE |
| Strength | 40MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA213057 |
| Applicant holder | ZYDUS LIFESCIENCES GLOBAL FZE |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Nov 20, 2019 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No 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.