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Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050753

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NDA 050753 describes TOBI, which is a drug marketed by Novartis Pharms and Novartis and is included in two NDAs. It is available from two suppliers. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TOBI profile page.

The generic ingredient in TOBI is tobramycin. There are eighteen drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the tobramycin profile page.

Summary for 050753

Tradename:	TOBI
Applicant:	Novartis Pharms
Ingredient:	tobramycin
Patents:	0
Therapeutic Class:	Antibacterials
Formulation / Manufacturing:	see details

Pharmacology for NDA: 050753

Ingredient-type	Aminoglycosides

Medical Subject Heading (MeSH) Categories for 050753

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 050753

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOBI	tobramycin	SOLUTION;INHALATION	050753	NDA	Novartis Pharmaceuticals Corporation	0078-0494	N	0078-0494-71
TOBI	tobramycin	SOLUTION;INHALATION	050753	NDA AUTHORIZED GENERIC	Sandoz Inc	0781-7171	N	0781-7171-56

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INHALATION			Strength	300MG/5ML
Approval Date:	Dec 22, 1997	TE:	AN	RLD:	Yes

Expired US Patents for NDA 050753

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis Pharms	TOBI	tobramycin	SOLUTION;INHALATION	050753-001	Dec 22, 1997	➤ Try a Free Trial	➤ Try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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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 verifification 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.