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Refuse to Approve Dr. Reddy’s ANDA That cites Lunesta® as The Reference Listed Drug, Unless The Conditions Specified in The Petition Are Satisfied - CLOSED

KeyWord(s) cder, section 505 (q), anda no 91024, eszopclone tablets, Dr. Reddy's Laboratories, R-isomer, lunesta
Short title Refuse to Approve Dr. Reddy’s ANDA That cites Lunesta® as The Reference Listed Drug, Unless The Conditions Specified in The Petition Are Satisfied
Docket Item Code P
Center CDER
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