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5,854 catalysts · 18,987 approval · 5,811 phase readout · 5,000 device 510k · 4,728 grant · 3,012 8k filing · 2,000 device pma
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5,854 catalysts · 18,987 approval · 5,811 phase readout · 5,000 device 510k · 4,728 grant · 3,012 8k filing · 2,000 device pma
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MH grant. $42,426. PI: Jessica Smith
AG grant. $284,108. PI: Sungmin Nam
AG grant. $409,750. PI: Robert T Mankowski
DC grant. $41,032. PI: Mariel Lee Schroeder
VA grant. PI: Katherine Ann Gallagher
AG grant. $734,957. PI: Nadia Razaq Sutton
AG grant. $683,028. PI: Song Hu
GM grant. $75,052. PI: Ryan Alexander Herold
HL grant. $47,505. PI: Nathaniel Hyams
NS grant. $227,025. PI: BRICE Alan KUHL
DE grant. $45,037. PI: Alessandro Leo
HD grant. $331,764. PI: Andreea Alina Creanga
VA grant. PI: Julie Ann Kittel-Moseley
VA grant. PI: KENNETH M KAUFMAN
VA grant. PI: Rozalyn M. Anderson
VA grant. PI: JUSTIN M BACHMANN
VA grant. PI: Jessica M Ross
VA grant. PI: Nichole Goodsmith
VA grant. PI: Nipa P Kamdar
VA grant. PI: Frances Aunon
VA grant. PI: Wei Dong
VA grant. PI: Kristina L Bailey
VA grant. PI: William Dean Lack
AA grant. $40,186. PI: Brooke Ruth Hafer
CA grant. $37,613. PI: Collin James Harlan
AI grant. $11,187. PI: Lisa M Bebell
GM grant. $155,484. PI: JIAN ZHAO
VA grant. PI: Alex Bryant
DK grant. $74,632. PI: Madigan Snyder
VA grant. PI: Arianne K Baldomero
VA grant. PI: JONG H YOON
VA grant. PI: Jonathan D Cherry
MH grant. $43,420. PI: Jana Hicham Badrani
GM grant. $75,052. PI: Omar M. Hedaya
VA grant. PI: MARTIN J GALLAGHER
VA grant. PI: MONIQUE Eun Hee CHO
NS grant. $42,647. PI: Colista Sue West
NS grant. $33,538. PI: SEAN COLLIER
DA grant. $49,538. PI: Lily Torp
NS grant. $74,632. PI: THADDEUS KUNKEL
NS grant. $50,000. PI: Huaye Zhang
traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10 — Reason: Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface. — Status: Ongoing
Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157-13 — Reason: Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale. — Status: Ongoing
Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4501-14 — Reason: Presence of Particulate Matter: Hair was found in a prefilled syringe — Status: Ongoing
Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4505-14 — Reason: Presence of Particulate Matter: Hair was found in a prefilled syringe — Status: Ongoing
BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusion 213, LLC, El Paso, TX 79912, NDC 54365-401-29 — Reason: Lack of Assurance of Sterlity — Status: Ongoing
CA grant. $49,538. PI: Hina Shah
NS grant. $567,047. PI: David Matthew Smith
GM grant. $140,056. PI: Ruby Fried
GM grant. $312,417. PI: Dorian R Dodd