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GENTAMICIN SULFATE

ANDA

GENTAMICIN SULFATE | A064054 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

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 0.1% BASE

0 patents0 exclusivities▴

OINTMENT;TOPICAL | Approved: Apr 29, 1994

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Cosette Pharmaceuticals updated its applicant name from "Cosette" to "Cosette Pharms NC" for gentamicin sulfate (NDA 064054).

Old: COSETTE

New: COSETTE PHARMS NC

MODIFIEDApplicant Full Name7/1/2026

Cosette Pharmaceuticals changed its registered applicant name from Cosette Pharmaceuticals Inc to Cosette Pharmaceuticals NC Laboratories LLC for gentamicin sulfate (NDA 064054).

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC