You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 4, 2024

Details for New Drug Application (NDA): 212628

✉ Email this page to a colleague

« Back to Dashboard

NDA 212628 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 212628

Tradename:	TOBRAMYCIN
Applicant:	Gland Pharma Ltd
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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.