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150 catalysts · 3,728 phase readout · 2,093 8k filing · 276 earnings · 172 phase 2 completion · 152 grant · 133 drug shortage
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150 catalysts · 3,728 phase readout · 2,093 8k filing · 276 earnings · 172 phase 2 completion · 152 grant · 133 drug shortage
Product code: OAS. Advisory committee: Radiology. Type: Special
Product code: POV. Advisory committee: Hematology. Type: Traditional
Product code: QWJ. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Special
Product code: GXN. Advisory committee: Neurology. Type: Traditional
Product code: QJP. Advisory committee: Cardiovascular. Type: Special
Product code: JXI. Advisory committee: Neurology. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Special
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: EIH. Advisory committee: Dental. Type: Traditional
Product code: IYO. Advisory committee: Radiology. Type: Traditional
Aller-C Dietary Supplement
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: KPR. Advisory committee: Radiology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GWM. Advisory committee: Neurology. Type: Traditional
Product code: OBR. Advisory committee: Unknown. Type: Traditional
Product code: KRD. Advisory committee: Cardiovascular. Type: Traditional
Product code: SHQ. Advisory committee: Dental. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: HWC. Advisory committee: Orthopedic. Type: Traditional
Product code: QKB. Advisory committee: Radiology. Type: Traditional
Product code: MHX. Advisory committee: Cardiovascular. Type: Traditional
Product code: NGX. Advisory committee: Physical Medicine. Type: Traditional
Product code: JKA. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: LRK. Advisory committee: Dental. Type: Traditional
Product code: JKA. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: GDW. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: DQY. Advisory committee: Cardiovascular. Type: Traditional
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: OPP. Advisory committee: General Hospital. Type: Special
Product code: QRA. Advisory committee: Neurology. Type: Special
Product code: QKB. Advisory committee: Radiology. Type: Traditional
Product code: DYB. Advisory committee: Cardiovascular. Type: Traditional
Product code: MCW. Advisory committee: Cardiovascular. Type: Traditional
Product code: KLE. Advisory committee: Dental. Type: Traditional
Product code: CHL. Advisory committee: Clinical Chemistry. Type: Traditional
Gel Nail Polish Remover (15ml)
Good Brain Tonic 16 oz & 32 oz
Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01 — Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port — Status: Ongoing
0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-470-05, Unit of Sale NDC Number: 65219-470-30. — Reason: Lack of Assurance of Sterility — Status: Ongoing
0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case). — Reason: Lack of Assurance of Sterility — Status: Ongoing
Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3509-04 carton, NDC 0591-3509-54 pouch — Reason: CGMP Deviations: use of an unapproved raw material — Status: Ongoing
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of Use NDC: 65219-432-20, Unit of Sale NDC Number: 65219-432-85. — Reason: Lack of Assurance of Sterility — Status: Ongoing
0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 600047, Unit of Use NDC: 65219-468-05, Unit of Sale NDC Number: 65219-468-50. — Reason: Lack of Assurance of Sterility — Status: Ongoing
0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20. — Reason: Lack of Assurance of Sterility — Status: Ongoing