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FDA Approval Activities for this Drug…
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg, Able, 76-528 8/21/03 Butalbital, Acetaminophen, and Caffeine with Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg, Vintage ANDA 75-929 4/22/02 Butalbital, Acetaminophen, and Caffeine with Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg, West-ward Pharmaceutical Corp. ANDA 75-618 3/23/01 3/30/01 Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules USP, 50 mg/325 mg/40 mg/30 mg, Jerome Stevens ANDA 74-951 8/31/98 9/2/98 9/26/02 Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules USP Endo NDA 75-351 3/5/99 4/21/03 Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules USP, 50 mg/325 mg/40 mg/30 mg, Anabolic, ANDA 75-231 11/30/01 4/10/03 Butalbital, Acetaminophen and Caffeine Capsules USP, 50 mg/500 mg/40 mg, West-ward Pharmaceutical Corp. ANDA 40-261 10/28/98 1/12/99 Butalbital, Acetaminophen and Caffeine Solution, 50 mg/325 mg/40 mg, Mikart, ANDA 40-387 1/31/03 Butalbital, Acetaminophen and Caffeine Tablets USP, 50 mg/500 mg/40 mg, Able ANDA 40-394 7/23/01 Butalbital, Acetaminophen and Caffeine Tablets, USP, Vintage ANDA 40-511 8/27/03 Butalbital, Acetaminophen and Caffeine Tablets USP, Vintage ANDA 40-513 8/25/03 Butalbital, Acetaminophen and Caffeine Tablets USP, 50 mg/325 mg/40 mg, Able ANDA 40-390 7/23/01 Butalbital, Acetaminophen and Caffeine Tablets USP, 50 mg/500 mg/40 mg, West-ward Pharmaceutical ANDA 40-336 8/18/99 8/24/99 Butalbital, Acetaminophen and Caffeine Tablets, USP, 50 mg/500 mg/40 mg, Watson ANDA 40-267 7/30/98 7/30/98 9/26/02 Butalbital, Acetaminophen and Caffeine Tablets, USP, 50 mg/500 mg/40 mg, West-ward Pharmaceutical Corp. ANDA 40-261 Fiorinal with Codeine (butalbital, aspirin, caffeine, and codeine phosphate) Capsules, Novartis NDA 19-429/S-006 Butalbital, Acetaminophen and Caffeine Tablets, Mikart, Inc. Butalbital, Acetaminophen, Caffeine and Codeine Phosphate, Anabolic Laboratories | Butalbital, Acetaminophen & Caffeine Tablets, Mutual Pharma, Approval
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