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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 207444

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NDA 207444 describes TOBRAMYCIN, which is a drug marketed by Alcon Pharms Ltd, Alembic, Apotex Inc, Bausch And Lomb, Chartwell Rx, Gland Pharma Ltd, Somerset Theraps Llc, Alkem Labs Ltd, Amneal Pharms, Dr Reddys Labs Sa, Hikma, Luoxin Aurovitas, Lupin, Mankind Pharma, Micro Labs, Norvium Bioscience, 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 thirty 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 207444

Tradename:	TOBRAMYCIN
Applicant:	Somerset Theraps Llc
Ingredient:	tobramycin
Patents:	0

Pharmacology for NDA: 207444

Medical Subject Heading (MeSH) Categories for 207444

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 207444

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOBRAMYCIN	tobramycin	SOLUTION/DROPS;OPHTHALMIC	207444	ANDA	Medsource Pharmaceuticals	45865-119	45865-119-01	5 mL in 1 BOTTLE (45865-119-01)
TOBRAMYCIN	tobramycin	SOLUTION/DROPS;OPHTHALMIC	207444	ANDA	A-S Medication Solutions	50090-4190	50090-4190-0	1 BOTTLE in 1 CARTON (50090-4190-0) / 5 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.3%
Approval Date:	Jun 28, 2017	TE:	AT	RLD:	No

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