By: IPP Bureau
Last updated : August 21, 2026 5:19 pm
With this, Zydus Lifesciences now has 448 ANDA approvals and has filed 513 ANDAs with the USFDA as of June 30, 2026
Zydus Lifesciences has received final USFDA approval for its Abbreviated New Drug Application (ANDA) for Ascorbic Acid Injection USP, strengthening its portfolio of generic injectable products in the US market.
The approved product is available in 25,000 mg/50 mL and 5,000 mg/10 mL, both at a concentration of 500 mg/mL. It is primarily indicated for the short-term treatment of scurvy in adult and paediatric patients aged five months and older when oral administration is not possible, insufficient or contraindicated.
Zydus' product is a generic equivalent of Ascor Injection, the reference listed drug. The USFDA has designated the ANDA as a Competitive Generic Therapy (CGT).
Eligibility for the 180-day exclusivity applicable to certain CGTs is determined by the USFDA and, where applicable, begins from the first day of commercial marketing.
The product will be manufactured at Zydus' USFDA-approved injectable manufacturing facility at Jarod, near Vadodara, Gujarat, and marketed in the US by Zydus Pharmaceuticals (USA) Inc.
According to IQVIA MAT data for June 2026, the reference product recorded annual US sales of approximately $11.6 million.
With this approval, Zydus said the group now has 448 ANDA approvals and has filed 513 ANDAs with the USFDA as of June 30, 2026.