Orange Book product
TESTOSTERONE ENANTHATE 200MG/ML
Orange Book ANDA 091120 · HIKMA FARMACEUTICA PORTUGAL SA · Prescription
Key facts
| Proprietary name | TESTOSTERONE ENANTHATE |
|---|---|
| Active ingredients | TESTOSTERONE ENANTHATE |
| Strength | 200MG/ML |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | ANDA091120 |
| Applicant holder | HIKMA FARMACEUTICA PORTUGAL SA |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AO |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Sep 18, 2012 |
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.