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NDA

BETAXOLOL HYDROCHLORIDE | N019270 | SANDOZ INC

1 strength0 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

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

1 letter from Drugs@FDA

Date	Submission	Document
Feb 22, 2006	SUPPL -31	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.5% BASE

RLDAT

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Aug 30, 1985

No patent or exclusivity listings for this strength.