Collection: All Documents
All Documents listed in our collection, including:
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- Fast-Track Requests (Receive in 1 to 3 weeks)
Use the Search below to find what you are looking for by keywords such as manufacturer, product, number, etc.
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SAP – KidneyIntelX.Dkd (DEN200052, Renalytix AI, Inc.)
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Scientific Review of Carcinogen Bioassays on Cyclamate (CAC-CFSAN, 1984)
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SE Market Orders – Excel List (11/29/23 – 4/9/24)
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Selection Process Details – Director of STEM Outreach Staff (Office of Talent Solutions)
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Sombra Cosmetics FDA Records: 483, EIR, and Warning Letter (2024)
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Spreadsheet – Firms with FDA Warning Letters (2011–2024)
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Submissions to FDA from EyePoint Pharmaceuticals, Inc. regarding the 02/2024 Inspection
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Summary Basis of Approval Request – ANDAs 218366 (Carnegie Pharmaceuticals) & 214896 (Rubicon Research Private Ltd.)
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Summary Basis of Approval – CycloSPORINE Ophthalmic Emulsion (ANDA 209811, Deva Holding AS)
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Summary Basis of Approval – Glatiramer Acetate Injection Labeling (A203857, Approved Sept 25, 2024)
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Summary Basis of Approval – NDA019185 (Abbott Laboratories, Final Labeling, Requested by B. Braun)
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Summary Basis of Information – NDA #011459 (Comprehensive Review Documents)
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Summary Basis of Information – NDA #011795 (Comprehensive Review Documents)
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Tech Trade, LLC – Ready-Heat Infant Warming Mattress (Complaints & Investigations, Jan 2025)
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Tentative Approval Letter Request – ANDA 217989 (Mirabegron ER Tablets, QILU for Lupin Pharmaceuticals)
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Tentative Approval Letter – ANDA 217845 (Dehydrated Alcohol, Accord Healthcare Inc)
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Tentative Approval Letter – Estradiol Valerate & Dienogest (ANDA 202349, Watson Labs Inc)
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USP/IFU – Medical Device Inserts (Dec 2017: Pfizer, Integra, Baxter)
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VCRP Ingredient Statements for Jafra Cosmetics
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VCRP Ingredient Statements for Kolmar
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Veterinary Medicine Organizational Charts – FDA Center for Veterinary Medicine
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