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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) 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 019084 – Nizoral (Ketoconazole) Cream 2% Labeling and Package Insert
Regular price $104.95 USDRegular priceUnit price / per -
FDA NDA 020007, ZOFRAN PRESERVATIVE FREE, SANDOZ, 01/04/1991
Regular price $2,071.47 USDRegular priceUnit price / per -
FDA NDA 020103, ZOFRAN, SANDOZ, 12/31/1992
Regular price $1,737.63 USDRegular priceUnit price / per -
FDA NDA 050684, ZOSYN, WYETH PHARMS, 10/22/1993
Regular price $1,945.94 USDRegular priceUnit price / per -
FDA NDA 070292, CARBACHOL, Pharmafair
Regular price $271.73 USDRegular priceUnit price / per -
FDA NDA 201094, GLYDO, SAGENT PHARMS INC, 04/28/2014
Regular price $89.00 USDRegular priceUnit price / per -
FDA NDA 208232: CDER€™s DGE Division's response to OOPD regarding Mycapssa (dated 4/5/24)
Regular price $51.94 USDRegular priceUnit price / per -
FDA NDA 209637, OZEMPIC, NOVO, 12/05/2017
Regular price $89.00 USDRegular priceUnit price / per -
FDA NDA 209988, FUROSCIX, SCPHARMACEUTICALS, 10/07/2022
Regular price $89.00 USDRegular priceUnit price / per -
FDA NDA 214755: Review Files for the supplemental NDA application for Lumryz
Regular price $89.00 USDRegular priceUnit price / per -
FDA NDA 215256, WEGOVY, NOVO, 06/04/2021
Regular price $89.00 USDRegular priceUnit price / per -
FDA NDA 215866, MOUNJARO (AUTOINJECTOR), ELI LILLY AND CO, 05/13/2022
Regular price $89.00 USDRegular priceUnit price / per -
FDA NDA 216354, AUSTEDO XR, TEVA, 02/17/2023
Regular price $89.00 USDRegular priceUnit price / per