The application for the product to the US Food and Drug Administration (USFDA) was made by the company's subsidiary Wockhardt Bio AG, the Mumbai-based company said in a regulatory filing.
"Wockhardt Bio AG had filed this abbreviated new drug application (ANDA) in collaboration with Fresinius Kabi, Italy (FKAI) where the product development was completed," it added.
The ANDA will be manufactured commercially at FKAI, Mitim, Italy, it said.
Wockhardt stock closed 2.54 per cent down at Rs 727.60 on BSE.