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FDA ANDA 206873, GLATIRAMER ACETATE, SYNTHON PHARMS INC, 09/25/2024
Regular price $622.69 USDRegular priceUnit price / per -
FDA ANDA 207382 Approval Routing Summary (Zydus Pharmaceuticals)
Regular price $69.95 USDRegular priceUnit price / per -
FDA ANDA 207957, FLUTICASONE PROPIONATE, HIKMA, 05/26/2016
Regular price $111.95 USDRegular priceUnit price / per -
FDA ANDA 210317, OCTREOTIDE ACETATE, TEVA PHARMS USA INC, 12/05/2023
Regular price $588.45 USDRegular priceUnit price / per -
FDA ANDA 212299, DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL), ZYDUS LIFESCIENCES, 09/10/2020
Regular price $696.52 USDRegular priceUnit price / per -
FDA ANDA 214348, BUPIVACAINE LIPOSOME, HENGRUI PHARMA, 07/01/2024
Regular price $89.00 USDRegular priceUnit price / per -
FDA ANDA 214850, ERIBULIN MESYLATE, LONG GROVE PHARMS, 07/18/2024
Regular price $280.29 USDRegular priceUnit price / per -
FDA ANDA 215561 Approval Routing Summary for (Lupin)
Regular price $168.94 USDRegular priceUnit price / per -
FDA ANDA 215808, KETAMINE HYDROCHLORIDE, FRESENIUS KABI USA, 01/13/2023
Regular price $116.95 USDRegular priceUnit price / per -
FDA ANDA 216935, PREDNISOLONE ACETATE, LUPIN LTD, 08/02/2024
Regular price $285.64 USDRegular priceUnit price / per -
FDA ANDA 217231 Approval Routing Summary (Dr. Reddy’s)
Regular price $69.95 USDRegular priceUnit price / per -
FDA ANDA 217248 Approval Routing Summary (Alkem Labs)
Regular price $168.94 USDRegular priceUnit price / per -
FDA ANDA 217250, ERIBULIN MESYLATE, BAXTER HLTHCARE CORP, 10/01/2024
Regular price $225.95 USDRegular priceUnit price / per -
FDA ANDA 218281, ERIBULIN MESYLATE, JIANGXI QINGFENG, 06/28/2024
Regular price $203.95 USDRegular priceUnit price / per -
FDA Approval Routing Summary for ANDA # 213680 (Biocon)
Regular price $168.94 USDRegular priceUnit price / per -
FDA BLA 103705, RITUXAN, Genentech, 11/26/1997
Regular price $89.00 USDRegular priceUnit price / per -
FDA BLA 125057, Supplement S-400, Humira, Approved on October 17, 2016
Regular price $184.95 USDRegular priceUnit price / per -
FDA Certified SE Clearance Letter for 510(k) K041059
Regular price $89.00 USDRegular priceUnit price / per -
FDA De Novo (DEN130045) HeartFlow FFRCT v1.4
Regular price $89.00 USDRegular priceUnit price / per -
FDA Decision Memo and Letters for 510(k) K173352
Regular price $83.62 USDRegular priceUnit price / per -
FDA DEN 170022 QuantX
Regular price $625.88 USDRegular priceUnit price / per -
FDA Drug Approval, A086195, PROCTOFOAM HC
Regular price $227.95 USDRegular priceUnit price / per -
FDA Drug Approval, ANDA 212025, APOMORPHINE HYDROCHLORIDE
Regular price $684.75 USDRegular priceUnit price / per -
FDA Drug Approval, N017381, SILVADENE
Regular price $404.41 USDRegular priceUnit price / per -
FDA FCN 002035: Chemistry and Toxicology Review Memos and Correspondence
Regular price $282.43 USDRegular priceUnit price / per -
FDA FCN 1805; Submitted by Solvay Specialty Polymers USA, LLC
Regular price $241.74 USDRegular priceUnit price / per -
FDA FCN 2025, Submitted by Eastman Chemical Company
Regular price $210.54 USDRegular priceUnit price / per -
FDA FCN 2308
Regular price $201.95 USDRegular priceUnit price / per -
FDA FCN 694, submitted by Lubrizol, Ltd
Regular price $295.04 USDRegular priceUnit price / per -
FDA Food Contact Notification (FCN) 1933 – Isononanoic Acid Esters with Dipentaerythritol
Regular price $250.00 USDRegular priceUnit price / per -
FDA Food Contact Notification (FCN) 2197 - Chemistry & Toxicology Review
Regular price $379.67 USDRegular priceUnit price / per -
FDA Internal Memoranda for Color Additive Petitions – Spirulina Extract
Regular price $175.00 USDRegular priceUnit price / per -
FDA NDA 009193, COGENTIN, MERCK, 03/05/1954
Regular price $695.43 USDRegular priceUnit price / per -
FDA NDA 012015, COGENTIN, EPIC PHARMA LLC, 12/21/1959
Regular price $168.94 USDRegular priceUnit price / per -
FDA NDA 012575, ACTIFED W/ CODEINE, GLAXOSMITHKLINE, 01/00/1900
Regular price $506.25 USDRegular priceUnit price / per -
FDA NDA 014134, PROTOPAM CHLORIDE, BAXTER HLTHCARE CORP, 03/11/1964
Regular price $313.46 USDRegular priceUnit price / per