Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761427
Company: LIB THERAPEUTICS, INC.

Products on BLA 761427

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEROCHOL	LERODALCIBEP-LIGA	300MG/1.2ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761427

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/12/2025	ORIG-1	Approval		N/A	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761427Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/761427Orig1s000TOC.html