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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 212628

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NDA 212628 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 212628

Tradename:	TOBRAMYCIN
Applicant:	Gland
Ingredient:	tobramycin
Patents:	0

Pharmacology for NDA: 212628

Medical Subject Heading (MeSH) Categories for 212628

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 212628

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOBRAMYCIN	tobramycin	SOLUTION/DROPS;OPHTHALMIC	212628	ANDA	Belcher Pharmaceuticals, LLC	62250-110	62250-110-01	1 BOTTLE, PLASTIC in 1 CARTON (62250-110-01) / 5 mL in 1 BOTTLE, PLASTIC
TOBRAMYCIN	tobramycin	SOLUTION/DROPS;OPHTHALMIC	212628	ANDA	Gland Pharma Limited	68083-374	68083-374-01	1 BOTTLE, PLASTIC in 1 CARTON (68083-374-01) / 5 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.3%
Approval Date:	Mar 9, 2021	TE:	AT	RLD:	No

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