Strides Shasun announced that it has received approval from the United States Food & Drug Administration (USFDA) for Metronidazole Tablets USP, 250 mg and 500 mg.
The product received approval in 17 months under the new GDUFA (Generic Drug User Fee Amendments) regime.
It is ready for immediate launch, said the company's press release.
According to IMS data, the US market for Metronidazole Tablets USP, 250 mg and 500 mg is approximately $50 million.
The product will be manufactured at the company's oral dosage facility at Bangalore, and marketed by Strides in the US market.