Collection: Fast Track Requests
FDA documents available for fast-track requests typically delivered within 1 to 2 weeks. Our fast-track request service identifies previously requested and redacted documents for quick access.
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ANDA Approval Package – ANDA 075734 (Summary, Clinical Pharmacology, Chemistry, Label)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483s – iRhythm Technologies (FEI 3007208829 & 3021769057, ~7/31/2024) & Establishment Labs (Alajuela, Costa Rica, ~7/26/2024)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Hisun Pharmaceutical (Nantong) Co., Ltd. Animal Drugs & Feed Inspection (Nantong, China, 11/15/2019, FEI 3010956224)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Wisdom Pharmaceutical Co., Ltd. Animal Drugs & Feed Inspection (Haimen, China, 1/18/2019, FEI 3004486763)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483s to IRBs – Copies Request (Inspection Review Period)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Mol Belting Systems Inc. Inspection (Grand Rapids, MI, 10/29/2024, FEI 3000913784)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – YB Chemia LLC Inspection (Baldwin Park, CA, 10/24/2024, FEI 3017645574)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Pharmalogic Austin, LLC Inspection (Austin, TX, 11/21/2024, FEI 3029262794)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Vitane Pharmaceuticals, Inc. Inspection (Congers, NY, 10/23/2024, FEI 3009790403)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Amici Pharma Inc. Inspection (Melville, NY, 11/12/2024, FEI 3014357169)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Neil S. Sadick, MD Inspection (Sadick Anesthetic Surgery & Dermatology, New York, 10/09/2024, FEI 3005667986)
Regular price $69.00 USDRegular priceUnit price / per -
Dr. Han C. Phan 493 – EIR & Response (2024)
Regular price $69.00 USDRegular priceUnit price / per -
Applied Therapeutics – 483, EIR & Written Response (2024)
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 -
FDA Review Summary – NDA/BLA for Proleukin (May 1992, Pre-clinical Studies)
Regular price $69.00 USDRegular priceUnit price / per -
Labels – Reference Product ANDA 076512 (Cytarabine 100 mg/mL) Evaluation
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Church & Dwight Co., Inc; Hamamatsu/Queen’s Pet Imaging Center, LLC; Salus Medical LLC (Human Drugs, Oct 2024)
Regular price $69.00 USDRegular priceUnit price / per -
Approval Routing Summary – ANDA 217248 (Alkem Labs)
Regular price $69.00 USDRegular priceUnit price / per -
Approval Routing Summary – ANDA 206210 (Actavis Laboratories FL, Inc.)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483s – Salvona Technologies LLC (Hamilton, NJ, 10/18/2024, FEI 3009344346) & June Jacobs Labs, LLC (Moonachie, NJ, 11/04/2024, FEI 3002832995)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483s – Bausch Health US, LLC (Bridgewater, NJ, 11/07/2024, FEI 3010446985) & Davion, Inc. (North Brunswick, NJ, 07/17/2024, FEI 3009540947)
Regular price $69.00 USDRegular priceUnit price / per -
Inspection Reports – Stella & Chewy’s, LLC (Oak Creek, WI, FEI 3006177750; Inspection ID 963217)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483s – Health and Natural Beauty USA Corp (Piscataway, NJ, 10/15/2024, FEI 3011061274) & PMS4PMS LLC (Clarence, NY, 11/08/2024, FEI 3016774658)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Pine Pharmaceuticals, LLC Inspection (Tonawanda, NY, 9/30/2024, FEI 3010943533)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – AACE Pharmaceuticals, Inc. Inspection (Fairfield, NJ, 11/22/2024, FEI 3013433273)
Regular price $69.00 USDRegular priceUnit price / per -
Chemistry Review – Hydrocortisone Sodium Succinate Injection (ANDA 214050, CIPLA LTD)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Veeral S. Sheth, MD Inspection (University Retina and Macula Associates, PC)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Allen Y. Hu, MD Inspection (Hagerstown, MD, 9/27/2021, FEI 3019853004)
Regular price $69.00 USDRegular priceUnit price / per -
ANDA Approval File – A202868 (Glenmark, Potassium Chloride Capsule ER, Approved Jan 19, 2016)
Regular price $69.00 USDRegular priceUnit price / per -
Inspection Records – Lea-Way Farms Inc. (Blue Ridge Beef, Statesville, NC, FEI #3004763201, Inspection ID 1148035, End Date 08/03/2021)
Regular price $69.00 USDRegular priceUnit price / per -
Pediatric Written Request – CDER to Pharmacia & Upjohn (Minoxidil, NDA 018154, Nov 8, 2000)
Regular price $69.00 USDRegular priceUnit price / per -
Establishment Inspection Reports – API Manufacturers (2013–2024)
Regular price $69.00 USDRegular priceUnit price / per -
483 Responses – iRhythm Technologies
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483s – Pierre Fabre Pharmaceuticals & Yessar M. Hussain, MD (Parsippany NJ, 7/27/2022; Austin TX, 3/7/2022)
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 – CycloSPORINE Ophthalmic Emulsion (ANDA 209811, Deva Holding AS)
Regular price $69.00 USDRegular priceUnit price / per