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Abbott's hydromorphone HCI

Executive Summary

Knoll maintains that Abbott's ANDA suitability petition for hydromorphone in 30 ml single-dose vials for injection containing 0.2 mg/ml and 0.5 mg/ml concentrations is not legally approvable. Knoll says Abbott's reference drugs, Knoll's Dilaudid products, are not listed drugs since they are not new drugs. If Dilaudid-HP is the reference drug, the petition is still deficient, Knoll maintains, because Abbott proposes to change the indication for use and dilute the strength of Dilaudid-HP by almost two orders of magnitude. Further, Knoll says a product referencing Dilaudid-HP should not be eligible for approval until January 1994.
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PS011141

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