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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 050753

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NDA 050753 describes TOBI, which is a drug marketed by Viatris and is included in two NDAs. It is available from one supplier. There are four 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. Thirty-six suppliers are listed for this compound. Additional details are available on the tobramycin profile page.

Summary for 050753

Tradename:	TOBI
Applicant:	Viatris
Ingredient:	tobramycin
Patents:	0

Pharmacology for NDA: 050753

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	Viatris Specialty LLC	49502-345	49502-345-73	56 POUCH in 1 CARTON (49502-345-73) / 4 AMPULE in 1 POUCH (49502-345-99) / 5 mL in 1 AMPULE

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
Viatris	TOBI	tobramycin	SOLUTION;INHALATION	050753-001	Dec 22, 1997	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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