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Last Updated: December 11, 2024

Details for New Drug Application (NDA): 209621


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NDA 209621 describes TOBRAMYCIN SULFATE, which is a drug marketed by Apothecon, Baxter Hlthcare Corp, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Igi Labs Inc, Mylan Labs Ltd, Slate Run Pharma, Teva Pharms Usa, Watson Labs Inc, Xellia Pharms Aps, and Xgen Pharms, and is included in thirty-two NDAs. It is available from eleven suppliers. Additional details are available on the TOBRAMYCIN SULFATE profile page.

The generic ingredient in TOBRAMYCIN SULFATE is tobramycin sulfate. There are eighteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the tobramycin sulfate profile page.
Summary for 209621
Tradename:TOBRAMYCIN SULFATE
Applicant:Gland Pharma Ltd
Ingredient:tobramycin sulfate
Patents:0
Pharmacology for NDA: 209621
Suppliers and Packaging for NDA: 209621
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 209621 ANDA Gland Pharma Limited 68083-253 68083-253-25 25 VIAL, MULTI-DOSE in 1 CARTON (68083-253-25) / 2 mL in 1 VIAL, MULTI-DOSE (68083-253-01)
TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 209621 ANDA Gland Pharma Limited 68083-254 68083-254-25 25 VIAL, MULTI-DOSE in 1 CARTON (68083-254-25) / 2 mL in 1 VIAL, MULTI-DOSE (68083-254-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10MG BASE/ML
Approval Date:Feb 11, 2021TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 40MG BASE/ML
Approval Date:Feb 11, 2021TE:APRLD:No

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