Orange Book product
BETAPACE AF 60MG
Orange Book NDA 021151 · LEGACY PHARMA INC SEZC · Discontinued
Key facts
| Proprietary name | BETAPACE AF |
|---|---|
| Active ingredients | SOTALOL HYDROCHLORIDE |
| Strength | 60MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | NDA021151 |
| Applicant holder | LEGACY PHARMA INC SEZC |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Apr 2, 2003 |
At a glance
- None 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.