Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217650
Company: TEVA PHARM

Products on ANDA 217650

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SHEUR	ELAGOLIX, ESTRADIOL AND NORETHINDRONE ACETATE AND ELAGOLIX	300MG/1MG/0.5MG	CAPSULE	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217650

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/22/2025	ORIG-1	Tentative Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/217650Orig1s000TAltr.pdf