Viewing data from:

TOBRAMYCIN

ANDA

TOBRAMYCIN | A205501 | AMNEAL PHARMACEUTICALS OF NEW YORK LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: BETHKIS(TE code: AN)

API Supply Chain5 active DMFs10 inactive

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

TAPI NL BVTOBRAMYCIN

DMF 137131998

CHONGQING DAXIN PHARMACEUTICAL CO LTDTOBRAMYCIN USP

DMF 137741998

XELLIA PHARMACEUTICALS APSTOBRAMYCIN SULPHATE, NON-STERILE BULK

DMF 150212000

XELLIA PHARMACEUTICALS APSTOBRAMYCIN SULPHATE, USP STERILE BULK

DMF 156292001

LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTDTOBRAMYCIN

DMF 350422020

PHARMACHIM ECONOMIC CORPInactiveTOBRAMYCIN BASE

DMF 75781988

GUANGDONG QINGYUAN NEW NORTH RIVER PHARMACEUTICAL CO LTDInactiveTOBRAMYCIN

DMF 121281996

PHARMACHIM ECONOMIC CORPInactiveTOBRAMYCIN

DMF 137401998

PHARMACHIM ECONOMIC CORPInactiveTOBRAMYCIN

DMF 137391998

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveTOBRAMYCIN

DMF 137701998

XELLIA PHARMACEUTICALS APSInactiveTOBRAMYCIN SULFATE, USP STERILE

DMF 168102003

ALPHARMA APSInactiveTOBRAMYCIN BASE USP (NON-STERILE BULK)

DMF 190292005

ALPHARMA APSInactiveTOBRAMYCIN SULPHATE USP (NON-STERILE BULK)

DMF 190302005

CHONGQING DAXIN PHARMACEUTICAL CO LTDInactiveTOBRAMYCIN FORM-1 USP

DMF 195062006

LIVZON NEW NORTH RIVER PHARMACEUTICAL CO LTDInactiveTOBRAMYCIN (NON-STERILE, BULK FORM)

DMF 207242007

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 20, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 300MG/5ML

0 patents0 exclusivities▴

SOLUTION;INHALATION | Approved: Jul 13, 2015

No patent or exclusivity listings for this strength.