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 Drug Recalls 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… 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 | Butalbital, Aspirin, & Caffeine Capsules, Mutual Pharma, Approval | Butalbital, Acetaminophen, Caffeine w/Codeine Phosphate Capsules, West-ward Pharma, Supplier Addition | Butalbital, Aspirin and Caffeine Capsules, Mutual Pharma, Labeling Revision | Fiorinal with Codeine (butalbital, aspirin, caffeine, codeine phosphate) Capsules, Watson Labs, Labeling Revision | Fiorinal with Codeine (butalbital, aspirin, caffeine and codeine phosphate) Capsules, Watson Labs, Labeling Revision | Butalbital, Acetaminophen and Caffeine Tablets, Tablet, Concord Laboratories, Inc., Approval | Butalbital, Acetaminophen and Caffeine Tablets, Concord Laboratories, Inc., Approval | Butalbital, Acetaminophen and Caffeine Capsule, NexGen Pharmaceuticals, 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 | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2009 Betterchem.com