Last Updated: November 9, 2026

Details for New Drug Application (NDA): 201422

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NDA 201422 describes TOBRAMYCIN, which is a drug marketed by Alcon Pharms Ltd, Alembic, Apotex Inc, Bausch And Lomb Inc, 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, Hainan Poly, Hospira, Igi Labs Inc, Mylan Labs Ltd, 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 three 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 201422

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

Pharmacology for NDA: 201422

Medical Subject Heading (MeSH) Categories for 201422

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 201422

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOBRAMYCIN	tobramycin	SOLUTION;INHALATION	201422	ANDA	Ritedose Pharmaceuticals, LLC	76204-029	76204-029-56	14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INHALATION			Strength	300MG/5ML
Approval Date:	May 28, 2014	TE:	AN	RLD:	No

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