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Elite receives FDA nod for supplemental application for Hydromorphone

Elite Pharmaceuticals has received FDA approval for supplemental application for the manufacturing and packaging of Hydromorphone Hydrochloride USP 8mg.

The approval will allow the company to initiate the commercial manufacturing and packaging of the product for its sales.

The company’s marketing partner will distribute the product as part of a multi-product distribution agreement.

Hydromorphone hydrochloride is a member of the opioid analgesic and antitussive class which is used primarily for pain relief or as a cough suppressant.