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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 210915

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NDA 210915 describes TOBRAMYCIN, which is a drug marketed by Alcon Pharms Ltd, Alembic, Apotex Inc, Bausch And Lomb, Chartwell Rx, Gland, Somerset Theraps Llc, Alkem Labs Ltd, Amneal Pharms, Dr Reddys Labs Sa, Hikma, Luoxin Aurovitas, Lupin, Mankind Pharma, Micro Labs, Pharmobedient, Sun Pharm, Teva Pharms Usa, Amneal, Padagis Us, Apothecon, Baxter Hlthcare Corp, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Hospira, Igi Labs Inc, Mylan Labs Ltd, Slate Run Pharma, Watson Labs Inc, Xellia Pharms Aps, and Xgen Pharms, and is included in fifty-five NDAs. It is available from twenty-nine suppliers. Additional details are available on the TOBRAMYCIN profile page.

The generic ingredient in TOBRAMYCIN 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 210915

Tradename:	TOBRAMYCIN
Applicant:	Teva Pharms Usa
Ingredient:	tobramycin
Patents:	0

Pharmacology for NDA: 210915

Medical Subject Heading (MeSH) Categories for 210915

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 210915

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOBRAMYCIN	tobramycin	SOLUTION;INHALATION	210915	ANDA	Teva Pharmaceuticals USA, Inc.	0093-3750	0093-3750-28	7 POUCH in 1 CARTON (0093-3750-28) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE
TOBRAMYCIN	tobramycin	SOLUTION;INHALATION	210915	ANDA	Teva Pharmaceuticals USA, Inc.	0093-3750	0093-3750-63	14 POUCH in 1 CARTON (0093-3750-63) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INHALATION			Strength	300MG/4ML
Approval Date:	Jun 26, 2019	TE:	AN	RLD:	No

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