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Generated: May 29, 2017

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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 Sandoz Inc 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. Twelve suppliers are listed for this compound. Additional details are available on the brimonidine tartrate profile page.

Summary for NDA: 021764

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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