Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Generated: July 16, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201422

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NDA 201422 describes TOBRAMYCIN, which is a drug marketed by Alcon Pharms Ltd, Alembic Pharms Ltd, Apotex Inc, Bausch And Lomb, Fera Pharms, Somerset Theraps Llc, Akorn Inc, Amneal Pharms, Dr Reddys Labs Sa, Lupin, Mylan, Teva Pharms Usa, Akorn, Apothecon, Baxter Hlthcare Corp, Fresenius Kabi Usa, Hospira, Igi Labs Inc, Mylan Labs Ltd, Watson Labs Inc, West-ward Pharms Int, X Gen Pharms, and Xellia Pharms Aps, and is included in forty NDAs. It is available from twenty-one suppliers. Additional details are available on the TOBRAMYCIN profile page.

The generic ingredient in TOBRAMYCIN is tobramycin sulfate. There are eighteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the tobramycin sulfate profile page.
Summary for 201422
Tradename:TOBRAMYCIN
Applicant:Akorn Inc
Ingredient:tobramycin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201422
Medical Subject Heading (MeSH) Categories for 201422
Suppliers and Packaging for NDA: 201422
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOBRAMYCIN tobramycin SOLUTION;INHALATION 201422 ANDA Akorn, Inc. 17478-340 17478-340-38 14 POUCH in 1 CARTON (17478-340-38) > 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:May 28, 2014TE:ANRLD:No

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