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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below to find the documents you are looking for by common criteria such as name, company, classification, date, etc.
below to find the documents you are looking for by common criteria such as name, company, classification, date, etc.Can't find what you are looking for? Submit a Custom Request.
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FDA 483 – Shree Jaya Laboratories Private Limited Inspection (Telangana, India, 09/12/2024, FEI 3011845012)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Suzhou Suncadia Biopharmaceuticals Co., Ltd. (FEI 3015786877, 15-Dec-2024–12-Jan-2025, Suzhou, Jiangsu, China)
Regular price $69.00 USDRegular priceUnit price / per -
Label Request – Methylene Blue Injection (ANDA 217561, 216959, 216955)
Regular price $69.00 USDRegular priceUnit price / per -
EIR Summary & FDA 483 – Zhejiang Haisen Pharmaceutical Co., Ltd. (Xianzhuang, Weishanzhen Dongyang, Jinhua, China)
Regular price $69.00 USDRegular priceUnit price / per -
EIR Request – Harman Finochem Limited Inspection (Industrial Area Chikalthana, Aurangabad, India)
Regular price $69.00 USDRegular priceUnit price / per -
BE Review Package – ANDA 213195 (Naltrexone ER Injectable Suspension, 380 mg/vial, Single-Dose)
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 -
FDA 483 – Patheon Italia S.p.A. Biologics Inspection (Monza, Italy, 11/18/2022, FEI 3003065803)
Regular price $69.00 USDRegular priceUnit price / per -
Inspection Records – Zhejiang Tianyu Pharmaceutical Co Ltd (FEI 3010972581, Jiangkou Development Zone, Huangyan, Taizhoushi, China)
Regular price $69.00 USDRegular priceUnit price / per -
Approval Letters – ANDAs: 213926 (Emtricitabine/Renofovir alafenamide, 12/13/2024); 216608 (Aripiprazole, 12/03/2024); 218787 (Darolutamide, 11/22/2024); 218544 (Nilotinib, 10/02/2024)
Regular price $69.00 USDRegular priceUnit price / per -
Approval Letter Request – ANDA 217714 (Esomeprazole Magnesium DR Oral Suspension 2.5 mg & 5 mg, Approved Jan 07, 2025)
Regular price $69.00 USDRegular priceUnit price / per -
EIR Request – Redacted EIRs (Nov 01–Dec 31, 2024)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Zen Chemicals Pvt. Ltd. (Issued ~03/28/2023)
Regular price $69.00 USDRegular priceUnit price / per -
Inspection Records – Sharp Clinical Services, LLC (Bethlehem, PA, 09/02/2022, FEI 3003673570, Drugs)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483s – Patheon Italia S.p.A. Inspection (Monza, Italy, 09/03/2021, FEI 3003065803)
Regular price $69.00 USDRegular priceUnit price / per -
FOIA Request – ANDA Tentative Approval Letter (Amneal EU Ltd, ANDA 218862, Rifaximin 550 mg)
Regular price $69.00 USDRegular priceUnit price / per -
ANDA Approval Letter Request – ANDA 216937 (Nimodipine Oral Solution 3 mg/ml, Annora Pharma, Approved Jul 09, 2024)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Janssen Biotech, Inc. Inspection (Titusville, USA, 09/27/2024, FEI 2242843)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – GLOBAL CALCIUM PRIVATE LIMITED (Sipcot Industrial Complex, Krishnagiri, India, 29 Jul–02 Aug 2024, 6 Observations, APIs involved)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Sannova Analytical LLC (Somerset, NJ, 10/07/2020, FEI 3006067971); Sunandana Chandra, MD (Chicago, IL, 01/13/2020, FEI 3006028555)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Daniel M. Gruener, MD (Saint Louis, MO, 01/04/2020, FEI 3015219315); Cosmax USA, Corporation (Carteret, NJ, 03/17/2020, FEI 3002679704); ProFresh International Corp. (Philadelphia, PA, TBD)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Mylan Laboratories Limited, Inc. (FEI 3010453141, Indore SEZ Pharma Zone, India)
Regular price $69.00 USDRegular priceUnit price / per -
Approval Routing Summary – ANDA 215503 Drug Approval Package
Regular price $69.00 USDRegular priceUnit price / per -
FDA Inspection Records Request – Abington Memorial Hospital (now Jefferson Abington, Abington, PA; EIRs, 483s, AOIs, IRB Oversight)
Regular price $69.00 USDRegular priceUnit price / per -
ANDA Feedback Request – ANDA 218544 (Nilotinib, Control #2024‑8919)
Regular price $69.00 USDRegular priceUnit price / per -
BLA Approval Letter Request – Aplisol (Tuberculin PPD Injection, BLA STN 103782, Issued 10/31/1972, Endo Operations Ltd)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Pedro Velasquez‑Mieyer, MD (FEI 3031753125)
Regular price $69.00 USDRegular priceUnit price / per -
EIR Status – Inspection at Site FEI #3002647489 (July 21–25, 2024, Drugs)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Ningbo Shuangcheng Pharmaceutical Co., Ltd. (Ningbo, China, Inspection Ended Nov 03, 2023, FEI 3014148045)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Alcami Carolinas Corporation (Saint Louis, USA, Inspection Ended Oct 04, 2024, FEI 1942094)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – International Laboratories Corp., Limited Inspection (Bang Phli, Samut Prakan, Thailand, 09/20/2024, FEI 3006403166)
Regular price $69.00 USDRegular priceUnit price / per -
Approval Documents Request – Human Factors Studies for ANDA 215503 (Liraglutide, Approved Dec 23, 2024)
Regular price $69.00 USDRegular priceUnit price / per -
Labeling Request – BLA 021684 Gonal‑F RFF Redi‑Ject (Follitropin Alfa/Beta, All Levels)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – CSL Behring (Australia) Pty Ltd Inspection (Broadmeadows, VIC, Australia, 03/08/2024, FEI 3001644620)
Regular price $69.00 USDRegular priceUnit price / per -
FDA Inspection Reports – Fresenius Kabi USA, LLC (483s & Warning Letters, Melrose Park, IL, 2023–2024)
Regular price $69.00 USDRegular priceUnit price / per -
FDA 483 – Polpharma Biologics S.A. Inspection (Gdansk, Poland, 03/22/2022, FEI 3013195136)
Regular price $69.00 USDRegular priceUnit price / per