FDA Approval Activities for this Drug…

Cromolyn Sodium Nasal Solution USP, OTC Bausch & Lomb ANDA 75-702 7/3/01 12/17/01 Cromolyn Sodium Nasal Solution USP, OTC L. Perrigo Co. ANDA 75-427 12/12/01 Cromolyn Sodium Nasal Solution USP, OTC Alpharma ANDA 74-800 7/26/01 6/11/02 Cromolyn Sodium Inhalation Solution USP, 20 mg/2 mL ampules, Bausch & Lomb ANDA 75-585 12/21/00 3/5/01 Cromolyn Sodium Inhalation Solution USP, 10 mg/mL (packaged in 20 mg/2 mL unit-dose vials), Novex Pharma ANDA 75-333 4/30/02 Cromolyn Sodium Inhalation Solution USP, 10 mg/mL (packaged in 2 mL unit-dose vials), Steripak Limited ANDA 75-271 1/18/00 2/4/00 12/26/01 12/26/01 Cromolyn Sodium Inhalation Solution USP, 10 mg/mL Roxane, ANDA 75-175 9/30/99 10/4/99 1/2/02 1/2/02 Cromolyn Sodium Inhalation Solution USP, 20 mg/2 mL Alpharma, U.S. ANDA 75-067 7/19/99 7/29/99 7/11/01 Cromolyn Sodium Ophthalmic Solution, 4%, Novex Pharma ANDA 75-615 1/26/01 3/5/01 Cromolyn Sodium Ophthalmic Solution, 4% Alcon, ANDA 75-282 6/16/99 6/17/99 Cromolyn Sodium Ophthalmic Solution, 10 mg/mL Morton Grove ANDA 75-346 10/25/99 12/30/99 Cromoptic (Cromolyn Sodium Ophthalmic Solution USP, 4%) King ANDA 75-088 Gastrocrom (cromolyn sodium, USP) Concentrate, NasalCrom Nasal Solution (cromolyn sodium nasal solution) Nasal Spray. Pharmacia Consumer Healthcare NDA 20-463/S-002 CROMOLYN SODIUM Aerosol, Metered; Inhalation 0.8MG/INH INTAL AVENTIS 020479 CROMOLYN SODIUM Solution, Concentrate; 100MG/5ML GASTROCROM CELLTECH 074706 AT CROMOLYN SODIUM Solution/Drops; Ophthalmic 4% CROMOLYN SODIUM Akorn 075282 AT CROMOLYN SODIUM Solution/Drops; Ophthalmic 4% CROMOLYN SODIUM Alcon 018155 AT CROMOLYN SODIUM Solution/Drops; Ophthalmic 4% OPTICROM ALLERGAN 074443 AT CROMOLYN SODIUM Solution/Drops; Ophthalmic 4% CROLOM BAUSCH AND LOMB 075615 AT CROMOLYN SODIUM Solution/Drops; Ophthalmic 4% CROMOLYN SODIUM Novex 075067 AN CROMOLYN SODIUM Solution; Inhalation 10MG/ML CROMOLYN SODIUM ALPHARMA 018596 AN CROMOLYN SODIUM Solution; Inhalation 10MG/ML INTAL AVENTIS 075585 AN CROMOLYN SODIUM Solution; Inhalation 10MG/ML CROMOLYN SODIUM BAUSCH AND LOMB 074209 AN CROMOLYN SODIUM Solution; Inhalation 10MG/ML CROMOLYN SODIUM Dey 075271 AN CROMOLYN SODIUM Solution; Inhalation 10MG/ML CROMOLYN SODIUM Ivax 075346 AN CROMOLYN SODIUM Solution; Inhalation 10MG/ML CROMOLYN SODIUM Morton Grove 075333 AN CROMOLYN SODIUM Solution; Inhalation 10MG/ML CROMOLYN SODIUM Novex 075175 AN CROMOLYN SODIUM Solution; Inhalation 10MG/ML CROMOLYN SODIUM Roxane 075437 AN CROMOLYN SODIUM Solution; Inhalation 10MG/ML CROMOLYN SODIUM WARRICK Intal (cromolyn sodium) Inhaler, Aventis Pharmaceuticals Intal (cromolyn sodium) Nebulizer, Aventis Pharmaceuticals NasalCrom Nasal Allergy Symptom Prevention Spray, Pfizer, Labeling Revision

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