← FDA Drug Approvals (Drugs@FDA)
TESTOSTERONE UNDECANOATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA PHARMACEUTICALS USA INC · Approved 2016-12-09
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
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