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… 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 | Cromolyn Sodium Nasal Solution, QPharma, Approval | Cromolyn Sodium Oral Concentrate, Genera Pharmaceuticals, Approval | Cromolyn Sodium Oral Solution, Pack Pharmaceuticals, LLC, Approval ^ FDA's latest approval appears at the bottom of this list. ^                                                                       A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2012 Betterchem.com