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BRIMONIDINE TARTRATE

Approved
Approval ID

6b660d4c-5df1-4f38-a0c3-82fd1353faa7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 14, 2011

Manufacturers
FDA

STAT RX USA LLC

DUNS: 786036330

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

BRIMONIDINE TARTRATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code16590-883
Application NumberANDA076260
Product Classification
M
Marketing Category
C73584
G
Generic Name
BRIMONIDINE TARTRATE
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 27, 2009
FDA Product Classification

INGREDIENTS (1)

BRIMONIDINE TARTRATEActive
Quantity: 2 mg in 1 mL
Code: 4S9CL2DY2H
Classification: ACTIB

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BRIMONIDINE TARTRATE - FDA Drug Approval Details