← FDA Drug Approvals (Drugs@FDA)
ELAGOLIX
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: TEVA PHARMS INC · Approved 2025-01-02
Drug application
- FDA Application #
ANDA217642- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- ELAGOLIX
- Generic name
- Elagolix
- Active ingredients
- ELAGOLIX
- Dosage form
- TABLET
- Route
- FILM COATED
- Marketing status
- None (Tentative Approval)
- Sponsor
- TEVA PHARMS INC
- First approval
- 2025-01-02
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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