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FDA Approval Activities for this Drug…
Biaxin Filmtab and BiaxinŽ Granules, Abbott NDA 50-697/S2 & 50-698/S14 5/24/02 6/17/02 BIAXIN XL Tablets (clarithromycin extended-release) Abbott NDA 50-775 3/3/00 3/7/00 3/7/00 10/11/01 BIAXIN XL Filmtab (clarithromycin) Extended-release Tablets, 500 mg, Abbott NDA 50-775/S4 4/11/03 4/18/03 BIAXIN XL Filmtab (clarithromycin) extended-release Abbott NDA 50-775/S1 8/3/01 11/5/01 11/5/01 11/23/01 Biaxin XL Indication: for Acute Bacterial Exacerbation of Chronic Bronchitis (AECB) and Acute Maxillary Sinusitis Biaxin (clarithromycin tablets, USP) Filmtab, Abbott NDA 50-662/S30 & S31 6/6/02 6/17/02 Biaxin (clarithromycin) Filmtab, 250 mg, Abbott NDA 50-662/S029 10/20/00 10/30/00 10/30/00 11/23/01 Biaxin XL Indication: provides for the addition of Haemophilus influenzae to the previously approved indication of Community-Acquired Pneumonia for Biaxin Filmtab (clarithromycin tablets). Biaxin (clarithromycin) Filmtab, Granules Abbott NDA 50-775/S Clarithromycin Tablets Roxane Laboratories Clarithromycin Extended-release Tablets, Andrx Pharmaceuticals Biaxin (clarithromycin) for MAC Treatment, Abbott Laboratories, Labeling Revision Biaxin Filmtabs (clarithromycin) tablets, Abbott Laboratories, Labeling Revision Biaxin Granules (clarithromycin) for Oral Suspension, Abbott Laboratories, Labeling Revision Biaxin XL Filmtabs (clarithromycin) extended-release tablets, Abbott Laboratories, Labeling Revision PrevPac (Lansoprazole/Amoxicillin/Clarithromycin), TAP Pharmaceutical, Labeling Revision | Clarithromycin Tablets, Ranbaxy Inc., Approval | Clarithromycin Extended-Release Tablets, Ranbaxy, Approval | Clarithromycin Tablets, Genpharm Inc., Approval | PREVPAC (lansoprazole/amoxicillin/clarithromycin), TAP Pharma, Labeling Revision | Clarithromycin Extended-Release Tablets, Teva Pharma, Approval | Clarithromycin Tablets, Ivax Pharma, Approval | Clarithromycin Tablets, Teva Pharma, Approval | Clarithromycin Tablets, Sandoz, Approval | Clarithromycin Extended-Release Tablets, Sandoz, Approval | Biaxin Filmtabs (clarithromycin tablets), Abbott Labs, Labeling Revision | Biaxin Granules (clarithromycin oral suspension), Abbott Labs, Labeling Revision | Biaxin XL Filmtabs (clarithromycin extended release tablets), Abbott Labs, Labeling Revision | Clarithromycin Tablets, Sandoz, Approval | Clarithromycin Tablets, Wockhardt Ltd., Approval | Biaxin (Clarithromycin) Filmtab, Abbott Labs, Labeling Revision | Biaxin (Clarithromycin) Granules, Abbott Labs, Labeling Revision | Biaxin XL (Clarithromycin) Filmtab, Abbott Labs, Labeling Revision | PREVPAC (lansoprazole/amoxicillin/clarithromycin), TAP Pharma, Labeling Revision
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