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1,390 catalysts · 3,048 8k filing · 2,253 grant · 1,170 approval · 1,000 device adverse event · 885 device 510k · 633 device pma
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1,390 catalysts · 3,048 8k filing · 2,253 grant · 1,170 approval · 1,000 device adverse event · 885 device 510k · 633 device pma
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Sponsor: RUBICON RESEARCH. Form: TABLET. Route: SUBLINGUAL
Sponsor: TARO. Form: TABLET. Route: ORAL
Sponsor: MANKIND PHARMA. Form: CAPSULE. Route: ORAL
Sponsor: LGM PHARMA. Form: TABLET. Route: ORAL
Sponsor: RISING. Form: TABLET. Route: ORAL
Sponsor: SANDOZ INC. Form: FOR SUSPENSION. Route: ORAL
Sponsor: GLENMARK PHARMS LTD. Form: SUSPENSION. Route: ORAL
Sponsor: ZYDUS PHARMS. Form: INJECTABLE. Route: INJECTION
Sponsor: ACTAVIS ELIZABETH. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: AMNEAL PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: GLAND. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Sponsor: UPSHER SMITH LABS. Form: SUSPENSION/DROPS. Route: OTIC
Sponsor: HIKMA. Form: SOLUTION. Route: ORAL
Sponsor: HIKMA. Form: SOLUTION. Route: ORAL
Sponsor: HIKMA. Form: SOLUTION. Route: ORAL
Sponsor: HIKMA. Form: SOLUTION. Route: ORAL
Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL
Sponsor: VISTAPHARM LLC. Form: SOLUTION. Route: ORAL
Sponsor: VISTAPHARM LLC. Form: SOLUTION. Route: ORAL
Sponsor: VISTAPHARM LLC. Form: SOLUTION. Route: ORAL
Sponsor: VISTAPHARM LLC. Form: SOLUTION. Route: ORAL
Sponsor: SANALUZ. Form: TABLET. Route: ORAL
Sponsor: STRIDES PHARMA INTL. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL
Sponsor: RISING. Form: TABLET. Route: ORAL
Sponsor: NOVEL LABS INC. Form: SOLUTION. Route: ORAL
Sponsor: NOVEL LABS INC. Form: SOLUTION. Route: ORAL
Sponsor: NOVEL LABS INC. Form: SOLUTION. Route: ORAL
Sponsor: NOVEL LABS INC. Form: SOLUTION. Route: ORAL
Sponsor: SAREPTA THERAPS INC. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: GLAND. Form: POWDER. Route: INTRAVENOUS, SUBCUTANEOUS
Sponsor: KNACK. Form: INJECTABLE. Route: INJECTION
Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: ACCORD HLTHCARE. Form: TABLET. Route: ORAL
Sponsor: HEBEI CHANGSHAN. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: EPIC PHARMA LLC. Form: TABLET. Route: ORAL
Sponsor: BIOCON BIOLOGICS INC. Form: INJECTABLE. Route: INJECTION
Sponsor: HUMANWELL. Form: TABLET. Route: ORAL
Sponsor: HUMANWELL. Form: TABLET. Route: ORAL
Sponsor: MYLAN. Form: TABLET. Route: ORAL-28
Sponsor: MICRO LABS LTD INDIA. Form: TABLET. Route: ORAL
Sponsor: INNOGENIX. Form: TABLET. Route: ORAL
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
Sponsor: XCOVERY. Form: CAPSULE. Route: ORAL
Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: ZYDUS LIFESCIENCES. Form: TABLET. Route: ORAL