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FDA 510(k), SmartCardia 7L Platform, Steurer Consulting Group LLC
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), SPECIALTY 55 & MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENSES FOR DAILY WEAR, CLEARLAB PTE LTD.
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), STRATIFY JCV DXSELECT, FOCUS DIAGNOSTICS, INC.
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), TRAVELAIRE, B & F MEDICAL PRODUCTS, INC.
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), UNI-SET, INHALATION THERAPY EQUIPMENT, CO.
Regular price $49.00 USDRegular priceUnit price / per -
FDA ANDA 013601, MUCOMYST, APOTHECON, 09/14/1963
Regular price $653.72 USDRegular priceUnit price / per -
FDA ANDA 205976 Approval Routing Summary (Endo)
Regular price $69.95 USDRegular priceUnit price / per -
FDA ANDA 206210 Approval Routing Summary (Actavis Laboratories FL, Inc.)
Regular price $168.94 USDRegular priceUnit price / per -
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 $9.95 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 BLA 103705, RITUXAN, Genentech, 11/26/1997
Regular price $9.95 USDRegular priceUnit price / per -
FDA Drug Approval, ANDA 212025, APOMORPHINE HYDROCHLORIDE
Regular price $684.75 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 694, submitted by Lubrizol, Ltd
Regular price $295.04 USDRegular priceUnit price / per -
FDA Food Contact Notification (FCN) 2197 - Chemistry & Toxicology Review
Regular price $379.67 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 -
FDA NDA 016798, SINEQUAN, PFIZER, 09/23/1969
Regular price $1,304.69 USDRegular priceUnit price / per -
FDA NDA 018687, NORMODYNE, SCHERING, 08/01/1984
Regular price $921.22 USDRegular priceUnit price / per -
FDA NDA 018932, REVIA, TEVA WOMENS, 11/20/1984
Regular price $1,675.57 USDRegular priceUnit price / per -
FDA NDA 020007, ZOFRAN PRESERVATIVE FREE, SANDOZ, 01/04/1991
Regular price $2,071.47 USDRegular priceUnit price / per