Viewing data from:

GENTAMICIN SULFATE

ANDA

GENTAMICIN SULFATE | A064048 | BAUSCH AND LOMB INC

1 strength0 unique patents0 unique exclusivities

API Supply Chain4 active DMFs9 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

FUJIAN FUKANG PHARMACEUTICAL CO LTDGENTAMICIN SULFATE

DMF 120481996

LEK PHARMACEUTICALS DDGENTAMICIN SULFATE

DMF 137041998

ACS DOBFAR SPAGENTAMICIN SULFATE

DMF 241982010

LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTDGENTAMICIN SULFATE

DMF 306932016

SCHERING PHARMACEUTICAL CORPInactiveGENTAMICIN SULFATE

DMF 134371998

GIST-BROCADES NV PHARMACEUTICALSInactiveGENTAMICIN SULFATE

DMF 136201998

PHARMACHIM ECONOMIC CORPInactiveGENTAMICIN SULFATE

DMF 136251998

SHANGHAI ASIA PIONEER PHARMACEUTICALS CO LTDInactiveGENTAMICIN SULFATE

DMF 136301998

SICHUAN LONG MARCH PHARMACEUTICAL CO LTDInactiveGENTAMICIN SULFATE

DMF 136371998

MEIJI SEIKA KAISHA LTDInactiveGENTAMICIN SULFATE

DMF 136581998

ANSA ANTIBIOTIK VE ILAC HAMMADDERI SANAYI A SInactiveGENTAMICIN SULFATE

DMF 136711998

YANTAI NO 2 PHARMACEUTICAL FACTORYInactiveGENTAMICIN SULFATE

DMF 148662000

HENAN KAIFENG PHARMACEUTICAL FACTORYInactiveGENTAMICIN SULFATE

DMF 199162006

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

Products (1)

#001 — EQ 0.3% BASE

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: May 11, 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 registered applicant name to Bausch and Lomb Inc for gentamicin sulfate (NDA 064048).

Old: BAUSCH AND LOMB PHARMACEUTICALS INC

New: BAUSCH AND LOMB INC

MODIFIEDApplicant7/1/2026

Bausch and Lomb's applicant name for Gentamicin Sulfate (NDA 064048) 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