# TESTOSTERONE UNDECANOATE
> **ANDA207583** · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA PHARMACEUTICALS USA INC · Approved 2016-12-09
## Drug
- **FDA Application Number:** ANDA207583
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** TESTOSTERONE UNDECANOATE
- **Generic name:** Testosterone Undecanoate
- **Active ingredients:** TESTOSTERONE UNDECANOATE
- **Dosage form:** INJECTABLE
- **Route:** INTRAMUSCULAR
- **Marketing status:** None (Tentative Approval)
- **Sponsor:** HIKMA PHARMACEUTICALS USA INC
- **First approval:** 2016-12-09
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207583)
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