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12,117 catalysts · 3,642 8k filing · 2,280 grant · 1,740 approval · 1,112 device 510k · 1,000 device adverse event · 815 device pma
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12,117 catalysts · 3,642 8k filing · 2,280 grant · 1,740 approval · 1,112 device 510k · 1,000 device adverse event · 815 device pma
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9262-08. — Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. — Status: Ongoing
Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NDC 60687-775-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217. — Reason: Failed tablet specifications. — Status: Ongoing
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-25; 69208-003-35 — Reason: Failed Tablet/Capsule Specifications — Status: Ongoing
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03. — Reason: Lack of Assurance of Sterility — Status: Ongoing
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional
Product code: HLZ. Advisory committee: Ophthalmic. Type: Traditional
Product code: SHN. Advisory committee: Radiology. Type: Traditional
Product code: NUC. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: DXN. 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: EZD. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: MOS. Advisory committee: Radiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: FOZ. Advisory committee: General Hospital. Type: Special
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Supplement type: Real-Time Process. Product code: NQO. Advisory committee: OR. Decision: APPR
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: NQR. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MGB. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: PHP. Advisory committee: MG. Decision: OK30
Supplement type: 30-Day Notice. Product code: NQR. Advisory committee: NE. Decision: OK30
Supplement type: Special (Immediate Track). Product code: PYX. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: NKE. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: QPY. Advisory committee: PM. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MAF. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: QVG. Advisory committee: CV. Decision: OK30
ES grant. $699,950. PI: Karlene A Cimprich
NS grant. $261,311. PI: ROBERT C. WELSH
VA grant. PI: Clark William DuMontier
MH grant. $427,625. PI: Larissa Elena Regina Albantakis
EY grant. $444,500. PI: LISA A Jordan
ES grant. $644,459. PI: COURTNEY Elizabeth Williams SULENTIC
DK grant. $252,000. PI: Carolina Ines Eliscovich
AG grant. $1,703,843. PI: Kelly Bakulski
MH grant. $1,518,208. PI: Jennillee Wallace
GM grant. $432,417. PI: Aidan Gilchrist
DK grant. $667,788. PI: Kendra R Becker
AI grant. $358,218. PI: Paul L Bollyky
AI grant. $184,000. PI: Dianne B Mckay
GM grant. $566,250. PI: KWANG HUN LIM
DA grant. $744,728. PI: Karen Chan Osilla
MH grant. $708,139. PI: Reesha Patel
GM grant. $1,677,007. PI: YU YAMAGUCHI
DA grant. $501,606. PI: JACQUELINE M BARKER