Orange Book product
BENZAMYCIN 5%;3%
Orange Book NDA 050557 · VALEANT INTERNATIONAL SRL · Prescription
Key facts
| Proprietary name | BENZAMYCIN |
|---|---|
| Active ingredients | BENZOYL PEROXIDE, ERYTHROMYCIN |
| Strength | 5%;3% |
| Dosage form | GEL |
| Route | TOPICAL |
| Application | NDA050557 |
| Applicant holder | VALEANT INTERNATIONAL SRL |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | Yes |
| Approval date | Oct 26, 1984 |
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.