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Details for New Drug Application (NDA): 021764

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NDA 021764 describes QOLIANA, which is a drug marketed by Alcon Pharms Ltd and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the QOLIANA profile page.

The generic ingredient in QOLIANA is brimonidine tartrate. There are eleven drug master file entries for this compound. Thirteen suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the brimonidine tartrate profile page.

Summary for NDA: 021764

Alcon Pharms Ltd
brimonidine tartrate
Therapeutic Class:Ophthalmic Agents

Pharmacology for NDA: 021764

Mechanism of ActionAdrenergic alpha-Agonists

Suppliers and Packaging for NDA: 021764

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC 021764 NDA Physicians Total Care, Inc. 54868-6094 54868-6094-0 10 mL in 1 BOTTLE (54868-6094-0)
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC 021764 NDA Sandoz Inc 61314-144 61314-144-05 5 mL in 1 BOTTLE (61314-144-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.15%
Approval Date:May 22, 2006TE:ATRLD:No
Patent:7,265,117Patent Expiration:Aug 19, 2025Product Flag?YSubstance Flag?Delist Request?

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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.