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5,854 catalysts · 18,987 approval · 6,271 phase readout · 5,000 device 510k · 4,728 grant · 3,350 8k filing · 2,000 device pma
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5,854 catalysts · 18,987 approval · 6,271 phase readout · 5,000 device 510k · 4,728 grant · 3,350 8k filing · 2,000 device pma
no tagged catalysts yet
CA grant. $5,000. PI: TERRY L. SHEPPARD
MH grant. $416,859. PI: Hongbing Wang
HG grant. $785,329. PI: Kevin Daniel Corbett
BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:info@omnilens.in, Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11. — Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. — Status: Ongoing
Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30. — Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. — Status: Ongoing
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA. Manufactured for and distributed by hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260. NDC 77790-001-10. — Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. — Status: Ongoing
Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80 — Reason: Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion. — Status: Ongoing
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15. — Reason: Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution. — Status: Ongoing
Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phase-3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-002-10. — Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. — Status: Ongoing
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA, — Reason: Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber. — Status: Ongoing
Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase-3, RIICO Industrial Area, Bhiwadi-901019, INDIA, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-022-15. — Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. — Status: Ongoing
Agebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 850065597027 — Reason: Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren — Status: Ongoing
Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula, 10 ml (1/3 fl.oz.), Wizcure Pharmaa PVT. LTD., H-881, Phase 3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ 85260, NDC 77790-003-10. — Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. — Status: Ongoing
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 8 50065 59701 0 — Reason: Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren — Status: Ongoing
CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India, — Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. — Status: Ongoing
CA grant. $10,000. PI: Ken Chen
AR grant. $556,651. PI: Matthew K Abramowitz
DK grant. $1,934,914. PI: Ashley Nicole Battarbee
NS grant. $419,920. PI: SARA J ATON
GM grant. $409,941. PI: Aaron Harvey Morris
MH grant. $442,750. PI: Lauren Marie Schaefer
HL grant. $44,751. PI: Abhishek Vijay Thakkar
CA grant. $550,210. PI: Shawn Hingtgen
GM grant. $406,112. PI: Jie Sun
GM grant. $406,026. PI: Yaojun Zhang
GM grant. $432,569. PI: Simou Sun
EB grant. $662,737. PI: Yanliang Zhang
DC grant. $2,387,184. PI: JACK M FLETCHER
MH grant. $208,794. PI: Emily Lauren Tilstra-Ferrell
DE grant. $555,081. PI: Christina Scherrer
MH grant. $445,816. PI: Jennifer Blumenthal-Barby
GM grant. $123,687. PI: Owen Funk
MH grant. $843,322. PI: Ragy Ramsis Girgis
AG grant. $214,223. PI: Robert Edward Burke
OD grant. $434,110. PI: Jenni Shearston
MH grant. $710,563. PI: Christine M Constantinople
GM grant. $433,125. PI: Amy C Rowat
GM grant. $449,625. PI: Samagya Banskota
DK grant. $655,482. PI: VIKAS DUDEJA
NS grant. $75,880. PI: Christopher David Adam
MH grant. $641,828. PI: Hume Akahori Stroud
AG grant. $121,239. PI: Mara Getz Sheftel
MH grant. $820,196. PI: Stephen P Becker
MH grant. $779,797. PI: Rainbo Hultman
NS grant. $555,265. PI: Emily Rose Petrus
MH grant. $659,242. PI: Hyman Scott
DC grant. $124,686. PI: Eleonora Judith Beier
MH grant. $156,500. PI: Santiago Jose Arconada Alvarez
GM grant. $445,983. PI: Mark A PERRELLA
GM grant. $429,000. PI: Lauren Elizabeth Surface