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1,918 catalysts · 3,085 8k filing · 1,751 grant · 1,000 device adverse event · 820 approval · 632 device 510k · 583 earnings
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1,918 catalysts · 3,085 8k filing · 1,751 grant · 1,000 device adverse event · 820 approval · 632 device 510k · 583 earnings
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parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL), Distributed by Haleon, Warren, NJ 07059. NDC 0135-0651-02 — Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles. — Status: Ongoing
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02. — Reason: Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution — Status: Ongoing
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway, NJ 08854, Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854, NDC 72205-070-72 — Reason: Failed Impurities/Degradation Specifications — Status: Ongoing
methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977. NDC 59762-4440-2 — Reason: Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil. — Status: Ongoing
INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01 — Reason: Failed Disintegration Specifications: above the time expected. — Status: Ongoing
AI grant. $439,250. PI: Matthew Daugherty
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HD grant. $35,832. PI: Pond Ezra
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AI grant. $443,850. PI: Kathryn A Knoop
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DE grant. $340,149. PI: Gina Lewin
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AI grant. $791,990. PI: PATRICK L SINN
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DK grant. $728,742. PI: Qunfeng Dong
DK grant. $773,901. PI: BRYAN R KESTENBAUM
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DK grant. $127,500. PI: Wade William Sugden
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AI grant. $191,163. PI: James D Weger
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DK grant. $588,892. PI: Adebowale Adebiyi
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AI grant. $421,223. PI: ELIZABETH Ann LEADBETTER
AI grant. $916,436. PI: RUDOLF JAENISCH