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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 050753


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NDA 050753 describes TOBI, which is a drug marketed by Mylan Speciality Lp and is included in two NDAs. It is available from one supplier. 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. Thirty-six suppliers are listed for this compound. Additional details are available on the tobramycin profile page.
Summary for 050753
Tradename:TOBI
Applicant:Mylan Speciality Lp
Ingredient:tobramycin
Patents:0
Pharmacology for NDA: 050753
Medical Subject Heading (MeSH) Categories for 050753
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 Mylan Specialty L.P. 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:RXDosage:SOLUTION;INHALATIONStrength300MG/5ML
Approval Date:Dec 22, 1997TE:ANRLD:Yes

Expired US Patents for NDA 050753

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speciality Lp TOBI tobramycin SOLUTION;INHALATION 050753-001 Dec 22, 1997 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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