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PROPARACAINE HYDROCHLORIDE

ANDA

PROPARACAINE HYDROCHLORIDE | A040074 | BAUSCH AND LOMB INC

1 strength0 unique patents0 unique exclusivities

API Supply Chain1 active DMF

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

SIEGFRIED LTDPROPARACAINE HYDROCHLORIDE

DMF 26981976

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: Sep 29, 1995

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Bausch and Lomb's applicant name for Proparacaine Hydrochloride (NDA 040074) was updated from "Bausch and Lomb" to "Bausch and Lomb Inc" in the FDA Orange Book.

Old: BAUSCH AND LOMB

New: BAUSCH AND LOMB INC

MODIFIEDApplicant Full Name7/1/2026

Bausch and Lomb Pharmaceuticals Inc changed its legal entity name to Bausch and Lomb Inc for the proparacaine hydrochloride ophthalmic product (NDA 040074).

Old: BAUSCH AND LOMB PHARMACEUTICALS INC

New: BAUSCH AND LOMB INC