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Generated: July 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050555

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NDA 050555 describes TOBREX, which is a drug marketed by Sandoz Inc and Novartis Pharms Corp and is included in three NDAs. It is available from five 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-seven suppliers are listed for this compound. Additional details are available on the tobramycin profile page.

Summary for NDA: 050555

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 050555

Ingredient-typeAminoglycosides

Suppliers and Packaging for NDA: 050555

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOBREX
tobramycin
OINTMENT;OPHTHALMIC 050555 NDA Alcon Laboratories, Inc. 0065-0644 0065-0644-35 3.5 g in 1 TUBE (0065-0644-35)
TOBREX
tobramycin
OINTMENT;OPHTHALMIC 050555 NDA STAT RX LLC USA 16590-225 16590-225-35 3.5 g in 1 TUBE (16590-225-35)

Summary for product number 001

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


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Serving 500+ biopharmaceutical companies globally:

Covington
Mallinckrodt
McKesson
Baxter
US Army
Express Scripts
Queensland Health
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Chubb
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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.

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