You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

Details for New Drug Application (NDA): 050753


✉ Email this page to a colleague

« Back to Dashboard


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 eight 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-three 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
Formulation / Manufacturing:see details
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

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.