The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Biaxin Filmtab Tablets, 250 mg. and 500 mg, of AbbVie Inc. (AbbVie).
Clarithromycin Tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in acute bacterial exacerbation of chronic bronchitis in adults; acute maxillary sinusitis; community-acquired pneumonia; pharyngitis/tonsillitis; uncomplicated skin and skin structure infections; acute otitis media in paediatric patients; treatment and prophylaxis of disseminated Mycobacterial infections; Helicobacter pylori infection and duodenal ulcer disease in adults.
Clarithromycin Tablets USP, 250 mg and 500 mg have an estimated market size of US$ 11 million for twelve months ending September 2021 according to IQVIA.
