Collection: Products
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510(k) Submission Documents – K955650
Regular price $69.00 USDRegular priceUnit price / per -
510(k) Submission Records – K173156
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510(k) Submission Records – PSM LOMAS / BENEFIT SCREWS (K110392)
Regular price $69.00 USDRegular priceUnit price / per -
510(k) Submission Request – PROTECTED BRONCHOALVEOLAR Lavage Balloon Catheter (K910536, Mill-Rose Laboratory)
Regular price $69.00 USDRegular priceUnit price / per -
510(k) Submission – CT SPACER (K010680, Clinical Technologies, Inc.)
Regular price $69.00 USDRegular priceUnit price / per -
510(k) Submission – Ivotion Base Print (K233995, Ivoclar Vivadent, Inc.)
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510(k) Submission – K230476
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510(k) Submission – NextDent Base (K231388, Vertex-Dental B.V.)
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510(k) Submission – NuVasive Precice Intramedullary Limb Lengthening System (K220234)
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510(k) Submission – Olympus (K182408)
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510(k) Submission – OVA1 Next Generation (K150588, Vermillion Inc)
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510(k) Submission – ProChamber Valved Holding Chamber (K032809, Respironics)
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510(k) Submission – ProChamber Valved Holding Chamber (K992917, Respironics HealthScan)
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Agreement & Amendments – Contract NNG15SD74B, Task Order 75F40123F80260 (APPIAN LICENSES)
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All MAFs - Primex Color, Compounding, and Additives (Including MAF Numbers & Related Info)
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Analysis Report – Stryker/TMJConcepts-522# PS110003/PSS001 (Time to Revision & Explant)
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ANDA 211287: Approval Letter, Routing Sheet, CRL
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ANDA Approval File – A202868 (Glenmark, Potassium Chloride Capsule ER, Approved Jan 19, 2016)
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ANDA Approval Letter Request – ANDA 216937 (Nimodipine Oral Solution 3 mg/ml, Annora Pharma, Approved Jul 09, 2024)
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ANDA Approval Package – ANDA 075734 (Summary, Clinical Pharmacology, Chemistry, Label)
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ANDA Approval Package – Naltrexone ER Injectable Suspension (ANDA 213195)
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ANDA Feedback Request – ANDA 218544 (Nilotinib, Control #2024‑8919)
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ANDA Review Documents – Paclitaxel Protein-bound Particles (ANDA 212700, Feb 03, 2022–Oct 08, 2024)
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Applied Therapeutics – 483, EIR & Written Response (2024)
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Approval Documents Request – Human Factors Studies for ANDA 215503 (Liraglutide, Approved Dec 23, 2024)
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Approval Documents – Lumryz (NDA #214755, Approval Letter, Labeling, REMS, Review Files, Sponsor Communications)
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Approval Letter Request – ANDA 217714 (Esomeprazole Magnesium DR Oral Suspension 2.5 mg & 5 mg, Approved Jan 07, 2025)
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Approval Letter – ANDA 215503 (Liraglutide, Approved Dec 23, 2024)
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Approval Letter – Prucalopride Succinate Tablets (EQ 1mg & 2mg, ANDA 218492, NOVITIUM PHARMA LLC)
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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)
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Approval Routing Summary for ANDA # 213719 (Zydus)
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Approval Routing Summary – ANDA 206210 (Actavis Laboratories FL, Inc.)
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Approval Routing Summary – ANDA 215503 Drug Approval Package
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Approval Routing Summary – ANDA 217248 (Alkem Labs)
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BE Review Package – ANDA 213195 (Naltrexone ER Injectable Suspension, 380 mg/vial, Single-Dose)
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BLA Approval Letter Request – Aplisol (Tuberculin PPD Injection, BLA STN 103782, Issued 10/31/1972, Endo Operations Ltd)
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