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Request to Amend the Approved Drug Products With Therapeutic Equivalence Evaluation List (the "Orange Book") to Assign a Second Reference - Listed Drug Product for Calcium Acetate Capsules

Type: Non-Rule Making
KeyWord(s) cder, 2013-70, therapeutic equivalence, Lupin, orange book, calcium acetate capsules, 667 mg, Fresenium MEDCL, NDA #N021160, Roxane, PHOSLO, capsule, open
Short title Requests to Amend the Orange Book to Assign a Second Reference - Listed Drug Product for Calcium Acetate Capsules
Docket Item Code P
Center CDER

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