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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 211847

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NDA 211847 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, Mylan, 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 211847

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

Pharmacology for NDA: 211847

Medical Subject Heading (MeSH) Categories for 211847

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 211847

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOBRAMYCIN	tobramycin	SOLUTION/DROPS;OPHTHALMIC	211847	ANDA	Alembic Pharmaceuticals Limited	46708-518	46708-518-05	1 BOTTLE in 1 CARTON (46708-518-05) / 5 mL in 1 BOTTLE
TOBRAMYCIN	tobramycin	SOLUTION/DROPS;OPHTHALMIC	211847	ANDA	Alembic Pharmaceuticals Inc.	62332-518	62332-518-05	1 BOTTLE in 1 CARTON (62332-518-05) / 5 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.3%
Approval Date:	Apr 19, 2019	TE:	AT	RLD:	No

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