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Refrain from Granting any Bioequivalence Waiver for any ANDA Referencing Duramed's NDA 21-544 for Seasonale - CLOSED

Type: Non-Rule Making
KeyWord(s) ANDA, oral contraceptive, estradio/0.15 mg, 0.30 mg ethinyl, Seasonale, 21-544, ANDA, Bioequivalence , Refrain from Granting , CDER
Short title Refrain from Granting any Bioequivalence Waiver for any ANDA Referencing Duramed's NDA 21-544 for Seasonale
Docket Item Code P
Center CDER

Primary Documents (1)