Orange Book product
ACCOLATE 20MG
Orange Book NDA 020547 · STRIDES PHARMA INTERNATIONAL AG · Prescription
Key facts
| Proprietary name | ACCOLATE |
|---|---|
| Active ingredients | ZAFIRLUKAST |
| Strength | 20MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | NDA020547 |
| Applicant holder | STRIDES PHARMA INTERNATIONAL AG |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | Yes |
| Approval date | Sep 26, 1996 |
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.