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Generated: January 19, 2019

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Details for New Drug Application (NDA): 205433

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NDA 205433 describes KITABIS PAK, which is a drug marketed by Pulmoflow Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the KITABIS PAK profile page.

The generic ingredient in KITABIS PAK 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 205433
Tradename:KITABIS PAK
Applicant:Pulmoflow Inc
Ingredient:tobramycin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205433
Medical Subject Heading (MeSH) Categories for 205433
Suppliers and Packaging for NDA: 205433
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KITABIS PAK tobramycin SOLUTION;INHALATION 205433 NDA Pari Respiratory Equipment 24492-850 24492-850-56 14 POUCH in 1 CARTON (24492-850-56) > 4 AMPULE in 1 POUCH > 5 mL in 1 AMPULE
KITABIS PAK tobramycin SOLUTION;INHALATION 205433 NDA AUTHORIZED GENERIC Genericus, Inc. 70644-899 70644-899-99 14 POUCH in 1 CARTON (70644-899-99) > 4 AMPULE in 1 POUCH > 5 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrength300MG/5ML
Approval Date:Dec 2, 2014TE:ANRLD:No

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