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5,854 catalysts · 18,987 approval · 5,811 phase readout · 5,000 device 510k · 4,728 grant · 2,984 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 · 2,984 8k filing · 2,000 device pma
no tagged catalysts yet
DK grant. $150,930. PI: Samantha Fortin
HL grant. $3,202,749. PI: Robyn Leagh McClelland
OD grant. $802,500. PI: Margaux Pinney
HL grant. $829,413. PI: NORRINA Bai ALLEN
HL grant. $697,200. PI: WENDY S POST
HL grant. $674,872. PI: KAROL E WATSON
HL grant. $505,956. PI: Alain Gerald Bertoni
CA grant. $897,500. PI: Jeffrey Michael Bethony
DE grant. $698,865. PI: Lucia H Cevidanes
GM grant. $132,000. PI: Rebecca E Scully
GM grant. $3,000. PI: Craig M Coopersmith
HL grant. $522,130. PI: Mete Civelek
AG grant. $49,438. PI: Jiachen Chen
Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA. NDC 51407-973-10 — Reason: Presence of Foreign Tablets/Capsules — Status: Ongoing
Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY 10532. NDC 51672-1351-08 — Reason: Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint — Status: Ongoing
Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL Multiple-dose vial, NDC 70069-161-01; 10x10mL Multiple-dose vials per Carton, NDC 70069-161-01. — Reason: Subpotent product:out of specification assay results observed during long term stability testing. — Status: Ongoing
Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Distributed by Benco Dental 295 Center Point Blvd, Pittston, PA 18640, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66975-406-51. — Reason: Defective container: cracked/broken cartridges — Status: Ongoing
Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01 — 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
darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66467-9760-5. — Reason: Defective container: cracked/broken cartridges — Status: Ongoing
3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-441-16. — Reason: Defective container: cracked/broken cartridges — Status: Ongoing
Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single dose 20mL vial NDC 70069-151-01; 10 x 20 Single dose vials per Carton, NDC 70069-151-10. — Reason: Subpotent product:out of specification assay results observed during long term stability testing. — Status: Ongoing
2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-176-16. — Reason: Defective container: cracked/broken cartridges — Status: Ongoing
OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL, Rx only, Made in Canada by Novocol Pharmaceutical of Canada, Inc., Distributed by Septodont, Inc., Louisville, Co, 80027, NDC 0362-0101-10 — Reason: Defective container: cracked/broken cartridges — Status: Ongoing
Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single-dose 5 mL vial NDC 70069-141-01; 10x5 mL single dose vial per Carton NDC 70069-141-10. — Reason: Subpotent product:out of specification assay results observed during long term stability testing. — Status: Ongoing
Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a carton containing 50 Single-Dose Cartridges, 1.7 mL, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0753-05. — Reason: Defective container: cracked/broken cartridges — Status: Ongoing
Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Patterson Dental Supply, Inc., 1031 Mendota Heights Road, Saint Paul, MN55120, Manufactured by: Novocol Pharmaceutical of Canada, Inc., NDC 50227-1030-5. — Reason: Defective container: cracked/broken cartridges — Status: Ongoing
MH grant. $181,224. PI: ALISA MO
Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Only, Manufactured for: Merck Sharpe & Dohme LLC, Rahway, NJ 07065, USA, Manufactured by: Novo Nordisk Production Ireland Limited Athlone, Ireland, NDC 0006-3066-03 — Reason: Presence of particulate matter: potential presence of metal particulates in the product. — Status: Ongoing
Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton, Rx Only, Manufactured for: Merck Sharp & Doohme LLC, Rahway, NJ 07056 USA, Manufactured by: N.V. Organon, 5349 AB Oss, The Netherlands, a subsidiary of Organon & Co., Jersey City, NJ 07302, USA NDC 0085-2224-02. — Reason: Presence of particulate matter: potential presence of metal particulates in the product. — Status: Ongoing
AG grant. $75,520. PI: Wesley T Richerson
AG grant. $49,538. PI: Dante Dennis Verendia Acenas II
HD grant. $49,538. PI: Alison Guyer
CA grant. $407,412. PI: Bryan Michael Burt
VA grant. PI: MICHAEL E. MATHENY
DC grant. $82,540. PI: Byron Howard Price
AG grant. $457,112. PI: Marcus E. Peter
AG grant. $695,789. PI: Michael Bienkowski
HL grant. $41,057. PI: Jesse Buffington
AG grant. $323,825. PI: Shariq Mohammed
DC grant. $238,502. PI: Lisa Soyeon Baik
AI grant. $85,563. PI: Vivek Kapur
VA grant. PI: Alina Valentina Dumitrescu
VA grant. PI: Brian Magne Andersen
VA grant. PI: SABRA INSLICHT
AR grant. $44,466. PI: Kaitlin Southern
AG grant. $656,829. PI: Kuan Hong Wang
AG grant. $542,699. PI: Yun Lei
AG grant. $657,000. PI: Hongjun Fu
DE grant. $47,454. PI: Kyle Vrej Kasparian
GM grant. $208,403. PI: Jason A. Avery