Orange Book product
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 10MG;6.25MG
Orange Book ANDA 212678 · EDENBRIDGE PHARMACEUTICALS LLC · Prescription
Key facts
| Proprietary name | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
|---|---|
| Active ingredients | BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE |
| Strength | 10MG;6.25MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA212678 |
| Applicant holder | EDENBRIDGE PHARMACEUTICALS LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Jul 9, 2020 |
At a glance
- 10–99 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.