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BRIMONIDINE

 
 
Content specific to this active ingredient…

Drug Information
Prescribing and patient information from leading authorities

Drug Master Files
Type 2 master files on file at the FDA

Safety Information
For prescription drugs containing this active ingredient

Exclusivity
Patent and market exclusivity data

Federal Register
FR search results for this API

FDA Approved Labelling
Information found in this drug's package inserts

Research Links
Chemical identification and research citations

Title 21 Code of Federal Regulations
FDA regulations for this API

 
 
 
 
 
 
 
 

 


 

FDA Approval Activities for this Drug…

Alphagan (brimonidine tartrate ophthalmic solution), 0.5, 0.2 & (P) 0.15%, Allergan NDA 20-490/S7, 20-613/S18 & 21-262/S6 12/20/01 6/19/02 6/19/02 6/19/02 Alphagan P (brimonidine tartrate ophthalmic solution), 0.15%, Allergan NDA 21-262 Brimonidine Tartrate Ophthalmic Solution, 0.2%, Bausch & Lomb ANDA 76-260 5/28/03 Brimonidine Tartrate Ophthalmic Solution, 0.2%, Alcon ANDA 76-254 9/16/03 Brimonidine Tartrate Ophthalmic Solution, 0.2%, Alcon Universal, Ltd. ANDA 76-254 Brimonidine Tartrate Ophthalmic Solution, Ivax Pharma, Approval | Alphagan P (brimonidine tartrate) ophthalmic solution, Allergan, , Approval | Alphagan P (brimonidine tartrate ophthalmic solution), Allergan, Labeling Revision | Alphagan P (brimonidine tartrate ophthalmic solution), Allergan, Inc., Labeling Revision | Brimonidine Tartrate Ophthalmic Solution, Alcon, Inc., Approval | COMBIGAN (brimonidine tartrate/timolol maleate) Ophthalmic Solution, Allergan Inc., Approval | Brimonidine Tartrate Ophthalmic Solution, Sandoz Inc., Approval | Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, Alcon Research, Ltd., Tentative Approval | Brimonidine Tartrate Ophthalmic Solution, Alcon Research, Ltd., Labeling Revision | Alphagan P (brimonidine tartrate) Ophthalmic Solution, Allergan, Inc., Labeling Revision | Alphagan P (brimonidine tartrate) Ophthalmic Solution, Allergan, Inc., Labeling Revision | Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, Hi-Tech Pharmacal Co., Inc., Tentative Approval | Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, Sandoz, Inc., Tentative Approval

^ FDA's latest approval appears at the bottom of this list. ^

                                                                   

 

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