Viewing data from:

TOBRAMYCIN AND DEXAMETHASONE

ANDA

DEXAMETHASONE; TOBRAMYCIN | A064134 | BAUSCH AND LOMB INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: TOBRADEX(TE code: AB)

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 27, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.1%;0.3%

0 patents0 exclusivities▴

SUSPENSION/DROPS;OPHTHALMIC | Approved: Oct 27, 1999

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 updated its corporate name to Bausch and Lomb Inc for the tobramycin and dexamethasone combination product (NDA 064134).

Old: BAUSCH AND LOMB PHARMACEUTICALS INC

New: BAUSCH AND LOMB INC

MODIFIEDApplicant7/1/2026

Bausch and Lomb's applicant name for tobramycin and dexamethasone (NDA 064134) was updated from "Bausch and Lomb" to "Bausch and Lomb Inc" in FDA records.

Old: BAUSCH AND LOMB

New: BAUSCH AND LOMB INC