Orange Book product
ISOTRETINOIN 30MG
Orange Book ANDA 205063 · ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC · Prescription
Key facts
| Proprietary name | ISOTRETINOIN |
|---|---|
| Active ingredients | ISOTRETINOIN |
| Strength | 30MG |
| Dosage form | CAPSULE |
| Route | ORAL |
| Application | ANDA205063 |
| Applicant holder | ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB2 |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Mar 31, 2021 |
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.