Orange Book product
OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML)
Orange Book ANDA 200219 · HIKMA FARMACEUTICA PORTUGAL SA · Prescription
Key facts
| Proprietary name | OXYTOCIN |
|---|---|
| Active ingredients | OXYTOCIN |
| Strength | 10USP UNITS/ML (10USP UNITS/ML) |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | ANDA200219 |
| Applicant holder | HIKMA FARMACEUTICA PORTUGAL SA |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Feb 13, 2013 |
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.