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OLOPATADINE

 
 
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…

Patanol (olopatadine hydrochloride ophthalmic solution), 0.1%, Alcon, NDA 20-688/S-016 4/17/03 | Patanol (olopatadine ophthalmic solution), 0.1%, Alcon NDA 20-688/S12 3/20/00 3/21/00 | Patanol Indications: Treatment of signs and symptoms of allergic conjunctivitis. | Olopatadine hydrochloride ophthalmic solution, Alcon, Inc., Approval | Olopatadine Hydrochloride Ophthalmic Solution, Alcon Research, Labeling Revision | Pataday (olopatadine hydrochloride) Ophthalmic Solution, Alcon Research, Labeling Revision | Pataday (olopatadine hydrochloride) Ophthalmic Solution, Alcon Research, Labeling Revision & Package Change | Olopatadine Hydrochloride Ophthalmic Solution, Apotex, Tentative Approval | Patanase (olopatadine hydrochloride) Nasal Spray, Alcon Research, Approval | Patanase Nasal Spray (olopatadine hydrochloride), Alcon Pharmaceuticals, Inc., Efficacy Supp w/Clinical Data | Patanase (olopatadine hydrochloride) Nasal Spray, Alcon Research, Ltd., Efficacy Supp. w/Clinical Data | Olopatadine Hydrochloride Ophthalmic Solution, Sandoz Inc., Tentative Approval | Patanase (olopatadine hydrochloride) Nasal Spray, Alcon Research, Ltd., Efficacy Supplement with Clinical Data to Support | Pataday (olopatadine hydrochloride) Ophthalmic Solution, Alcon, Inc., Labeling Revision | Olopatadine Hydrochloride Ophthalmic Solution, Barr Laboratories, Inc., Tentative Approval | Olopatadine Hydrochloride Ophthalmic Solution, Wockhardt, Ltd., Tentative Approval | Olopatadine hydrochloride Ophthalmic Drops, Apotex, Inc., Tentative Approval | Olopatadine Hydrochloride Ophthalmic Solution, Apotex Corp., Tentative Approval

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

                                                                   

 

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