Orange Book product
TESTOSTERONE 50MG/5GM PACKET
Orange Book ANDA 091073 · ACTAVIS LABORATORIES UT INC · Prescription
Key facts
| Proprietary name | TESTOSTERONE |
|---|---|
| Active ingredients | TESTOSTERONE |
| Strength | 50MG/5GM PACKET |
| Dosage form | GEL |
| Route | TRANSDERMAL |
| Application | ANDA091073 |
| Applicant holder | ACTAVIS LABORATORIES UT INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB2 |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Sep 18, 2017 |
At a glance
- 1–9 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.