← FDA Drug Approvals (Drugs@FDA)
RELUGOLIX
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SANDOZ INC · Approved 2026-09-02
Drug application
- FDA Application #
ANDA219913
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- RELUGOLIX
- Generic name
- Relugolix
- Active ingredients
- RELUGOLIX
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- SANDOZ INC
- First approval
- 2026-09-02
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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