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Serving leading biopharmaceutical companies globally:

US Department of Justice
Express Scripts

Generated: November 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050592

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NDA 050592 describes TOBRADEX, which is a drug marketed by Novartis Pharms Corp and is included in three NDAs. It is available from five suppliers. There are three patents protecting this drug. Additional details are available on the TOBRADEX profile page.

The generic ingredient in TOBRADEX is dexamethasone; tobramycin. There are thirty-nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the dexamethasone; tobramycin profile page.

Summary for 050592

Formulation / Manufacturing:see details

Pharmacology for NDA: 050592

Suppliers and Packaging for NDA: 050592

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
dexamethasone; tobramycin
SUSPENSION/DROPS;OPHTHALMIC 050592 NDA Alcon Laboratories, Inc. 0065-0647 0065-0647-05 5 mL in 1 BOTTLE, PLASTIC (0065-0647-05)
dexamethasone; tobramycin
SUSPENSION/DROPS;OPHTHALMIC 050592 NDA Alcon Laboratories, Inc. 0065-0647 0065-0647-10 10 mL in 1 BOTTLE, PLASTIC (0065-0647-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength0.1%;0.3%
Approval Date:Aug 18, 1988TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 050592

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp
dexamethasone; tobramycin
SUSPENSION/DROPS;OPHTHALMIC050592-001Aug 18, 1988► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Cantor Fitzgerald
Queensland Health
Chinese Patent Office
Daiichi Sankyo
Johnson and Johnson
Express Scripts

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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