Orange Book product
ZIAC 10MG;6.25MG
Orange Book NDA 020186 · TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D LLC · Prescription
Key facts
| Proprietary name | ZIAC |
|---|---|
| Active ingredients | BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE |
| Strength | 10MG;6.25MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | NDA020186 |
| Applicant holder | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | Yes |
| Approval date | Mar 26, 1993 |
At a glance
- 10–99 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.