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Generated: January 23, 2019

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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 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. Thirty-one suppliers are listed for this compound. Additional details are available on the tobramycin profile page.
Summary for 050753
Applicant:Mylan Speciality Lp
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 Novartis Pharmaceuticals Corporation 0078-0494 0078-0494-71 56 POUCH in 1 CARTON (0078-0494-71) > 4 AMPULE in 1 POUCH (0078-0494-91) > 5 mL in 1 AMPULE (0078-0494-61)
TOBI tobramycin SOLUTION;INHALATION 050753 NDA AUTHORIZED GENERIC Sandoz Inc 0781-7171 0781-7171-56 56 AMPULE in 1 CARTON (0781-7171-56) > 5 mL in 1 AMPULE (0781-7171-75)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrength300MG/5ML
Approval Date:Dec 22, 1997TE:ANRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

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