← FDA Drug Approvals (Drugs@FDA)
SHEUR
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: TEVA PHARM · Approved 2025-09-22
Drug application
- FDA Application #
ANDA217650
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- SHEUR
- Generic name
- Elagolix, Estradiol And Norethindrone Acetate And Elagolix
- Active ingredients
- ELAGOLIX, ESTRADIOL AND NORETHINDRONE ACETATE AND ELAGOLIX
- Dosage form
- CAPSULE
- Route
- —
- Marketing status
- Prescription
- Sponsor
- TEVA PHARM
- First approval
- 2025-09-22
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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