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FDA Approval Activities for this Drug…
Betaxolol Hydrochloride Tablets USP, 10 mg and 20 mg. Amide Pharmaceutical, ANDA 75-541 10/22/99 12/29/99 | | Betaxolol Ophthalmic Solution USP, 0.5%, Bausch & Lomb ANDA 75-630 4/12/01 4/13/01 Betaxolol Ophthalmic Solution USP, 0.5%, Bausch & Lomb ANDA 75-630 4/19/00 4/24/00 | Betaxolol Ophthalmic Solution USP, 0.5%, Novex Pharma ANDA 75-446 9/28/00 10/30/00 | Betaxolol Ophthalmic Solution USP, 0.5%, Akorn, ANDA 75-386 Betoptic S (betaxolol HCl ophthalmic suspension), 0.25%, Alcon NDA 19-845/S-017 BETAXOLOL HYDROCHLORIDE Solution/Drops; Ophthalmic 0.5% BASE BETAXOLOL Akorn | 019270 AT BETAXOLOL HYDROCHLORIDE Solution/Drops; Ophthalmic 0.5% BASE BETOPTIC Alcon | 075630 AT BETAXOLOL HYDROCHLORIDE Solution/Drops; Ophthalmic 0.5% BASE BETAXOLOL HCL BAUSCH AND LOMB | 075446 AT BETAXOLOL HYDROCHLORIDE Solution/Drops; Ophthalmic 0.5% BASE BETAXOLOL Novex | 019845 BETAXOLOL HYDROCHLORIDE Suspension/Drops; Ophthalmic 0.25% BASE BETOPTIC S Alcon | 075541 BETAXOLOL HYDROCHLORIDE Tablet; 10MG BETAXOLOL HCL Amide | 075541 BETAXOLOL HYDROCHLORIDE Tablet; 20MG BETAXOLOL HCL Amide | 019507 BETAXOLOL HYDROCHLORIDE Tablet; 10MG KERLONE LOREX | 019507 BETAXOLOL HYDROCHLORIDE Tablet; 20MG KERLONE LOREX | Betoptic (betaxolol HCl ophthalmic solution), Alcon Labs, Labeling Revision | Betoptic S (betaxolol hydrochloride) Ophthalmic Suspension, Alcon Research, Patient Population Altered | Betoptic S (betaxolol hydrochloride) Ophthalmic Suspension, Alcon, Labeling Revision | Betaxolol Hydrochloride Tablets, KVK-Tech, Inc., Approval | Kerlone (betaxolol hydrochloride) Tablets, Sanofi-Aventis US, LLC, Labeling Revision | Kerlone (betaxolol hydrochloride) Tablets, Sanofi-aventis, US, LLC, Labeling Revision | Betaxolol Ophthalmic Solution, Wockhardt Ltd., Approval | Kerledex (betaxolol hydrochloride and chlorthalidone) Tablet, Sanofi-Aventis, Labeling Revision | Kerlone (betaxolol hydrochloride) Tablets, sanofi-aventis, Labeling Revision | Kerledex (betaxolol hydrochloride and chlorthalidone) Tablets, sanofi-aventis, Labeling Revision
  
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