← FDA DRUG APPROVALS

FDA BLA · BLA761165

CIMERLI

ranibizumab-eqrn

Sponsor: SANDOZ INC

APPLICATION
BLA761165
TYPE
BLA
ORIGINAL APPROVAL
2022-08-02
LATEST ACTION
2024-05-21
ROUTE
INTRAVITREAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CIMERLIPrescription
RANIBIZUMAB-EQRN 0.5MG(10MG/ML) · INJECTABLE · INJECTION
CIMERLIPrescription
RANIBIZUMAB-EQRN 0.3MG(6MG/ML) · INJECTABLE · INJECTION

Approval history

2024-05-21Bioequivalence · Supplement 5 — Letter ↗AP
2022-08-02UNKNOWN · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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