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

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Medtronic
McKinsey
Merck
Express Scripts
AstraZeneca

Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050541

See Plans and Pricing

« Back to Dashboard

NDA 050541 describes TOBREX, which is a drug marketed by Novartis and Sandoz Inc and is included in three NDAs. It is available from eight suppliers. Additional details are available on the TOBREX profile page.

The generic ingredient in TOBREX is tobramycin. There are eighteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the tobramycin profile page.
Summary for 050541
Tradename:TOBREX
Applicant:Novartis
Ingredient:tobramycin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 050541
Medical Subject Heading (MeSH) Categories for 050541
Suppliers and Packaging for NDA: 050541
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOBREX tobramycin SOLUTION/DROPS;OPHTHALMIC 050541 NDA Alcon Laboratories, Inc. 0065-0643 0065-0643-05 1 BOTTLE, PLASTIC in 1 CARTON (0065-0643-05) > 5 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.3%
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:Yes

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
McKinsey
Dow
Merck
Colorcon
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.