← FDA DRUG APPROVALS

FDA BLA · BLA761094

OXERVATE

cenegermin-bkbj

Sponsor: DOMPE FARMACEUTICI

APPLICATION
BLA761094
TYPE
BLA
ORIGINAL APPROVAL
2018-08-22
LATEST ACTION
2023-10-20
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

OXERVATEPrescription
CENEGERMIN-BKBJ 0.002%(20MCG/ML) · SOLUTION · OPHTHALMIC

Approval history

2023-10-20Labeling · Supplement 12 · standard — Letter ↗AP
2023-10-20Labeling · Supplement 13 · standard — Letter ↗AP
2019-10-30Labeling · Supplement 1 · standard — Letter ↗AP
2018-08-22Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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