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NDA

LEVOBUNOLOL HYDROCHLORIDE | N019219 | ALLERGAN PHARMACEUTICAL

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

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 Chain2 active DMFs5 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

OLON SPALEVOBUNOLOL HYDROCHLORIDE

DMF 141951999

PIRAMAL PHARMA LTDLEVOBUNOLOL HYDROCHLORIDE

DMF 169042003

GOEDECKE AGInactiveLEVOBUNOLOL HYDROCHLORIDE (1-BUNOLOL HYDROCHLORIDE)

DMF 51131983

PHARMECO LABORATORIES INCInactiveLEVOBUNOLOL HYDROCHLORIDE

DMF 94811991

MEDICHEM SAInactiveLEVOBUNOLOL HYDROCHLORIDE

DMF 94821992

SUMITOMO CHEMICAL CO LTDInactiveLEVOBUNOLOL HYDROCHLORIDE

DMF 96521992

PLAISTOW LTDInactiveLEVOBUNOLOL HYDROCHLORIDE

DMF 115191995

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 27, 2017	SUPPL -29	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#002 — 0.5%

RLDAT

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Dec 19, 1985

No patent or exclusivity listings for this strength.