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FDA approval activities for this prescription 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

For the latest approval information, please locate this API using this index.


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