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7,525 catalysts · 3,350 8k filing · 1,096 grant · 1,000 device adverse event · 580 earnings · 550 approval · 430 device 510k
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7,525 catalysts · 3,350 8k filing · 1,096 grant · 1,000 device adverse event · 580 earnings · 550 approval · 430 device 510k
Product code: QXA. Advisory committee: Microbiology. Type: Dual Track
Product code: QAS. Advisory committee: Radiology. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: FMI. Advisory committee: General Hospital. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: OWB. Advisory committee: Radiology. Type: Abbreviated
Product code: NBC. Advisory committee: Clinical Chemistry. Type: Traditional
Supplement type: 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: QES. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LMF. Advisory committee: SU. Decision: OK30
AI grant. $10,000. PI: Nancy Ryan Gray
MH grant. $608,086. PI: Solange P Brown
GM grant. $429,797. PI: Zachary T. Berndsen
CA grant. $141,566. PI: Fatema Bhinderwala
CA grant. $618,236. PI: Yong Teng
NS grant. $722,338. PI: Jennifer A Kim
CA grant. $683,075. PI: Dipanjan Chowdhury
Sponsor: ALKEM LABS LTD. Form: CAPSULE. Route: ORAL
Sponsor: ENCUBE. Form: CREAM. Route: TOPICAL
Sponsor: PFIZER INC. Form: SOLUTION. Route: INJECTION
Sponsor: MERCK SHARP DOHME. Form: INJECTABLE. Route: INJECTION
Sponsor: CORCEPT THERAP. Form: CAPSULE. Route: ORAL
Sponsor: BRISTOL. Form: TABLET. Route: ORAL
Sponsor: GRANULES. Form: TABLET, EXTENDED RELEASE. Route: ORAL
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
Product code: DQO. Advisory committee: Cardiovascular. Type: Special
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FRO. Advisory committee: Unknown. Type: Traditional
Product code: OWI. Advisory committee: Orthopedic. Type: Traditional
Product code: BZE. Advisory committee: Anesthesiology. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Abbreviated
Product code: EOB. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: FMI. Advisory committee: General Hospital. Type: Special
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: LHN. Advisory committee: Radiology. Type: Traditional
Product code: HQC. Advisory committee: Ophthalmic. Type: Traditional
Supplement type: Real-Time Process. Product code: MFK. Advisory committee: OP. Decision: APPR
Supplement type: 30-Day Notice. Product code: MOM. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: NGV. Advisory committee: CV. Decision: APPR