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Generated: August 21, 2018

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Details for New Drug Application (NDA): 201820

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NDA 201820 describes BETHKIS, which is a drug marketed by Chiesi Usa Inc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the BETHKIS profile page.

The generic ingredient in BETHKIS is tobramycin. There are eighteen drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the tobramycin profile page.
Summary for 201820
Tradename:BETHKIS
Applicant:Chiesi Usa Inc
Ingredient:tobramycin
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 201820
Ingredient-typeAminoglycosides
Medical Subject Heading (MeSH) Categories for 201820
Suppliers and Packaging for NDA: 201820
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BETHKIS tobramycin SOLUTION;INHALATION 201820 NDA Chiesi USA, Inc. 10122-820 N 10122-820-28
BETHKIS tobramycin SOLUTION;INHALATION 201820 NDA Chiesi USA, Inc. 10122-820 N 10122-820-56

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrength300MG/4ML
Approval Date:Oct 12, 2012TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Sep 22, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Sep 22, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Jun 14, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF CYSTIC FIBROSIS PATIENTS

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