Viewing data from:

PENTOLAIR

ANDA

CYCLOPENTOLATE HYDROCHLORIDE | A040075 | BAUSCH AND LOMB INC

1 strength0 unique patents0 unique exclusivities

API Supply Chain2 active DMFs1 inactive

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

ESTEVE QUIMICA SACYCLOPENTOLATE HYDROCHLORIDE

DMF 72721987

C-SQUARED PHARMA LTDCYCLOPENTOLATE HYDROCHLORIDE

DMF 363422021

PHARMECO LABORATORIES INCInactiveCYCLOPENTOLATE HYDROCHLORIDE (P-637)

DMF 67591986

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

Products (1)

#001 — 1%

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Apr 29, 1994

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Bausch and Lomb updated the applicant name for Pentolair (cyclopentolate hydrochloride) from "Bausch and Lomb" to "Bausch and Lomb Inc" in the FDA Orange Book record.

Old: BAUSCH AND LOMB

New: BAUSCH AND LOMB INC

MODIFIEDApplicant Full Name7/1/2026

Bausch and Lomb Pharmaceuticals Inc. changed its registered applicant name to Bausch and Lomb Inc. for the cyclopentolate hydrochloride ophthalmic solution NDA 040075.

Old: BAUSCH AND LOMB PHARMACEUTICALS INC

New: BAUSCH AND LOMB INC