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FDA grants final approval for Aurobindo Ampicillin & Sulbactam for injection

The US Food & Drug Administration has granted final approval to India-based Aurobindo Pharma for its three ANDAs, as Ampicillin & Sulbactam for injection 1.5g and 3g (Infusion bottles), Ampicillin & Sulbactam for injection 1.5g and 3g (single-use vials) and Ampicillin & Sulbactam for injection 15g USP (Pharmacy Bulk Pack).

Aurobindo Pharma claims that Ampicillin & Sulbactam for injection USP is a Sterile Semi Synthetic Penicillin (SSP) product falling under the anti-infective segment and is generic equivalent to Pfizer’s Reference Listed Drug Unasyn for injections.

Ampicillin & Sulbactam for injection USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions such as skin and skin structure infections, intra-abdominal infections and gynecological infections.