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LEVOBUNOLOL HYDROCHLORIDE

ANDA

LEVOBUNOLOL HYDROCHLORIDE | A074326 | BAUSCH AND LOMB INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: BETAGAN(TE code: AT)

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.

Products (1)

#001 — 0.5%

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Mar 4, 1994

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant Full Name7/1/2026

Bausch and Lomb Pharmaceuticals Inc changed its corporate name to Bausch and Lomb Inc for levobunolol hydrochloride NDA 074326.

Old: BAUSCH AND LOMB PHARMACEUTICALS INC

New: BAUSCH AND LOMB INC

MODIFIEDApplicant7/1/2026

Bausch and Lomb's applicant name for levobunolol hydrochloride (NDA 074326) was updated from "Bausch and Lomb" to "Bausch and Lomb Inc" in the Orange Book.

Old: BAUSCH AND LOMB

New: BAUSCH AND LOMB INC