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KERLONE

NDA

BETAXOLOL HYDROCHLORIDE | N019507 | SANOFI AVENTIS US LLC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain3 active DMFs4 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

LUSOCHIMICA SPABETAXOLOL HYDROCHLORIDE

DMF 107271994

OLON SPABETAXOLOL HYDROCHLORIDE

DMF 172352004

INDOCO REMEDIES LTDBETAXOLOL HYDROCHLORIDE USP

DMF 253012011

LABORATOIRES DETUDES ET DE RECHERCHES SYNTHELABOInactiveBETAXOLOL

DMF 38001980

LABORATOIRES DETUDES ET DE RECHERCHES SYNTHELABOInactiveBETAXOLOL HYDROCHLORIDE

DMF 54641984

FINORGA SASInactiveBETAXOLOL HYDROCHLORIDE

DMF 62861986

SIFAVITOR SRLInactiveBETAXOLOL HYDROCHLORIDE

DMF 126801997

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 27, 1989

No patent or exclusivity listings for this strength.

#002 — 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 27, 1989