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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. $683,075. PI: Dipanjan Chowdhury
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1. — Reason: Lack of Assurance of Sterility — Status: Ongoing
Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, Made in India, NDC 51672-5321-8. — Reason: Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product. — Status: Ongoing
Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Annora Pharma Pvt. LTd., Sengareddy - 502313, Telengana, India, NDC 72603-479-01. — Reason: Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg — Status: Ongoing
Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Waukegan, IL 60085. — Reason: Microbial Contamination of Sterile Products: Affected lots have been deemed non-sterile following discovery of a contaminant (Paenibacillus phoenicis), which may pose a potential infection risk to vulnerable groups. — Status: Ongoing
Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873, NDC carton: 70069-025-10; NDC vial: 70069-025-01 — Reason: Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate. — Status: Ongoing
MH grant. $824,728. PI: Jyrki Ahveninen
CA grant. $593,338. PI: Lingtao Jin
TR grant. $3,091,157. PI: Afshin Beheshti
GM grant. $74,632. PI: Andria Pace
NR grant. $1,778,418. PI: Sarah N. Miller
DK grant. $720,353. PI: Aaron J Norris
NR grant. $1,804,481. PI: Teresa Brockie
MH grant. $827,879. PI: Alexander Friedman
CA grant. $215,976. PI: Kalyani Sonawane
DK grant. $43,313. PI: Elizabeth A Brown
CA grant. $521,002. PI: Luiz Eduardo Bertassoni
CA grant. $625,179. PI: Alexander E Davies
DA grant. $81,580. PI: William John Mitchell
HL grant. $38,224. PI: Phinea Z Romero
AI grant. $50,114. PI: Tracy Biaco
DE grant. $44,984. PI: Prasun K Datta
DK grant. $34,272. PI: Rebekka Hannah Anderson
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9259-08. — Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. — Status: Ongoing
Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Guajarat, INDIA NDC 33342-401-44 — Reason: Subpotent Drug — Status: Ongoing
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9257-08. — Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. — Status: Ongoing
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9262-08. — Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. — Status: Ongoing
Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NDC 60687-775-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217. — Reason: Failed tablet specifications. — Status: Ongoing
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-25; 69208-003-35 — Reason: Failed Tablet/Capsule Specifications — Status: Ongoing
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03. — Reason: Lack of Assurance of Sterility — Status: Ongoing
ES grant. $699,950. PI: Karlene A Cimprich
NS grant. $261,311. PI: ROBERT C. WELSH
VA grant. PI: Clark William DuMontier
MH grant. $427,625. PI: Larissa Elena Regina Albantakis
EY grant. $444,500. PI: LISA A Jordan
ES grant. $644,459. PI: COURTNEY Elizabeth Williams SULENTIC
DK grant. $252,000. PI: Carolina Ines Eliscovich
AG grant. $1,703,843. PI: Kelly Bakulski
MH grant. $1,518,208. PI: Jennillee Wallace
GM grant. $432,417. PI: Aidan Gilchrist
DK grant. $667,788. PI: Kendra R Becker
AI grant. $358,218. PI: Paul L Bollyky
AI grant. $184,000. PI: Dianne B Mckay
GM grant. $566,250. PI: KWANG HUN LIM
DA grant. $744,728. PI: Karen Chan Osilla
MH grant. $708,139. PI: Reesha Patel
GM grant. $1,677,007. PI: YU YAMAGUCHI
DA grant. $501,606. PI: JACQUELINE M BARKER
NS grant. $442,750. PI: Kyle Fink
MH grant. $1,130,348. PI: Simone Marini