www.accessdata.fda.gov

Score	Article	Date	Citations
2.5	Risk Evaluation and Mitigation Strategy (REMS) Document PALYNZIQ® (pegvaliase-pqpz) REMS https://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2023_12_09_REMS_Full.pdf	N/A	1
2.5	Establishment Registration & Device Listing https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm	N/A	1
2.5	Premarket Approval (PMA) - P000025/S104 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000025S104	N/A	1
2.5	Product Details for NDA 019810 https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=019810#3275	N/A	1
2.5	Drugs@FDA: FDA-Approved Drugs https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019839	N/A	1
2.5	Prozac (fluoxetine) Label https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s091lbl.pdf	N/A	1
2.5	Dawnzera: FDA-Approved Drugs https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219407	N/A	1
2.5	510(k) Summary – ArthroCare Coblator IQ ENT System https://www.accessdata.fda.gov/cdrh_docs/pdf12/K123353.pdf	N/A	1
2.5	Risk Evaluation and Mitigation Strategy (REMS) Document ZULRESSO (brexanolone) REMS Program https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211371Orig1s000REMS.pdf	N/A	1