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Generated: January 20, 2019

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Details for New Drug Application (NDA): 050814

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NDA 050814 describes CAYSTON, which is a drug marketed by Gilead and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the CAYSTON profile page.

The generic ingredient in CAYSTON is aztreonam. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the aztreonam profile page.
Summary for 050814
Tradename:CAYSTON
Applicant:Gilead
Ingredient:aztreonam
Patents:4
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 050814
Suppliers and Packaging for NDA: 050814
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAYSTON aztreonam FOR SOLUTION;INHALATION 050814 NDA Gilead Sciences, Inc. 61958-0901 61958-0901-1 2 CARTON in 1 PACKAGE (61958-0901-1) > 1 KIT in 1 CARTON * 1 mL in 1 VIAL * 1 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;INHALATIONStrength75MG/VIAL
Approval Date:Feb 22, 2010TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Dec 20, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:IMPROVE RESPIRATORY SYMPTOMS IN CYSTIC FIBROSIS IN PATIENTS WITH PSEUDOMONAS AERUGINOSA
Patent:➤ Sign UpPatent Expiration:Dec 20, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Dec 20, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:IMPROVE RESPIRATORY SYMPTOMS IN CYSTIC FIBROSIS IN PATIENTS WITH PSEUDOMONAS AERUGINOSA

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