Collection: Products
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PMTA Social Science Review Memo (June 25, 2020) – VERVE® Discs & Chews (Blue & Green Mint)
Regular price $69.00 USDRegular priceUnit price / per -
PMTA Submission – Lust Vapes LLC (Reg RG8850, Multiple STNs)
Regular price $69.00 USDRegular priceUnit price / per -
Public References – Final Rule Sec VII (21 CFR 172.829, FR Vol 67 No 131, July 9, 2002)
Regular price $69.00 USDRegular priceUnit price / per -
Quality Discipline Review – Octreotide Acetate Injectable (ANDA‑210317, TEVA PHARMS USA INC)
Regular price $69.00 USDRegular priceUnit price / per -
Recalls of Cosmetic and Personal Care Products (2016-2024)
Regular price $69.00 USDRegular priceUnit price / per -
Records Request – Natasha Phelps, Califf, King & Mital
Regular price $69.00 USDRegular priceUnit price / per -
Records Request – Restore Hyper Wellness & Related Entities (Vitaeris 320, Nicole Welch, etc.)
Regular price $69.00 USDRegular priceUnit price / per -
Records – FDA 510(k) Submission K172959
Regular price $69.00 USDRegular priceUnit price / per -
Records – Sodium Nitrite Incidents & Report (Feb 2021, Loudwolf, etc.)
Regular price $69.00 USDRegular priceUnit price / per -
Redacted FDA Decision Memorandum - Eli Lilly's Tirzepatide Drug Shortage (Dec 19, 2024)
Regular price $69.00 USDRegular priceUnit price / per -
Redacted Form 483 & Response – Mylan Laboratories Limited, Inc. (Indore, India, 06/14–26, 2024, FEI 3010453141)
Regular price $69.00 USDRegular priceUnit price / per -
Regulatory Records for Sombra Cosmetics, Inc.
Regular price $69.00 USDRegular priceUnit price / per -
Request – 510(k) Submission Records for Enspire 3000 (K230930, STERIS Corporation)
Regular price $69.00 USDRegular priceUnit price / per -
Request – Bactiseal Catheters & Accessories (K233445, with correspondence)
Regular price $69.00 USDRegular priceUnit price / per -
Request – Redacted Copies of 510(k)s (K130896 & K981624)
Regular price $69.00 USDRegular priceUnit price / per -
Response – CSL Behring L.L.C. Biologics Inspection (Bradley, IL, 10/18/2018, FEI 1410248)
Regular price $69.00 USDRegular priceUnit price / per -
SAP – KidneyIntelX.Dkd (DEN200052, Renalytix AI, Inc.)
Regular price $69.00 USDRegular priceUnit price / per -
Scientific Review of Carcinogen Bioassays on Cyclamate (CAC-CFSAN, 1984)
Regular price $69.00 USDRegular priceUnit price / per -
SE Market Orders – Excel List (11/29/23 – 4/9/24)
Regular price $69.00 USDRegular priceUnit price / per -
Selection Process Details – Director of STEM Outreach Staff (Office of Talent Solutions)
Regular price $69.00 USDRegular priceUnit price / per -
Sombra Cosmetics FDA Records: 483, EIR, and Warning Letter (2024)
Regular price $69.00 USDRegular priceUnit price / per -
Spreadsheet – Firms with FDA Warning Letters (2011–2024)
Regular price $69.00 USDRegular priceUnit price / per -
Submissions to FDA from EyePoint Pharmaceuticals, Inc. regarding the 02/2024 Inspection
Regular price $0.00 USDRegular priceUnit price / per -
Summary Basis of Approval Request – ANDAs 218366 (Carnegie Pharmaceuticals) & 214896 (Rubicon Research Private Ltd.)
Regular price $69.00 USDRegular priceUnit price / per -
Summary Basis of Approval – CycloSPORINE Ophthalmic Emulsion (ANDA 209811, Deva Holding AS)
Regular price $69.00 USDRegular priceUnit price / per -
Summary Basis of Approval – Glatiramer Acetate Injection Labeling (A203857, Approved Sept 25, 2024)
Regular price $69.00 USDRegular priceUnit price / per -
Summary Basis of Approval – NDA019185 (Abbott Laboratories, Final Labeling, Requested by B. Braun)
Regular price $69.00 USDRegular priceUnit price / per -
Summary Basis of Information – NDA #011459 (Comprehensive Review Documents)
Regular price $69.00 USDRegular priceUnit price / per -
Summary Basis of Information – NDA #011795 (Comprehensive Review Documents)
Regular price $69.00 USDRegular priceUnit price / per -
Tech Trade, LLC – Ready-Heat Infant Warming Mattress (Complaints & Investigations, Jan 2025)
Regular price $69.00 USDRegular priceUnit price / per -
Tentative Approval Letter Request – ANDA 217989 (Mirabegron ER Tablets, QILU for Lupin Pharmaceuticals)
Regular price $69.00 USDRegular priceUnit price / per -
Tentative Approval Letter – ANDA 217845 (Dehydrated Alcohol, Accord Healthcare Inc)
Regular price $69.00 USDRegular priceUnit price / per -
Tentative Approval Letter – Estradiol Valerate & Dienogest (ANDA 202349, Watson Labs Inc)
Regular price $69.00 USDRegular priceUnit price / per -
USP/IFU – Medical Device Inserts (Dec 2017: Pfizer, Integra, Baxter)
Regular price $69.00 USDRegular priceUnit price / per -
VCRP Ingredient Statements for Jafra Cosmetics
Regular price $69.00 USDRegular priceUnit price / per -
VCRP Ingredient Statements for Kolmar
Regular price $69.00 USDRegular priceUnit price / per