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Generated: January 22, 2019

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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 one supplier. 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. Eight suppliers are listed for this compound. Additional details are available on the brimonidine tartrate profile page.
Summary for 021764
Applicant:Sandoz Inc
Ingredient:brimonidine tartrate
Pharmacology for NDA: 021764
Mechanism of ActionAdrenergic alpha-Agonists
Medical Subject Heading (MeSH) Categories for 021764
Suppliers and Packaging for NDA: 021764
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QOLIANA brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021764 NDA Sandoz Inc 61314-144 61314-144-05 5 mL in 1 BOTTLE (61314-144-05)
QOLIANA brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021764 NDA Sandoz Inc 61314-144 61314-144-10 10 mL in 1 BOTTLE (61314-144-10)

Profile for product number 001

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

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