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21,882 catalysts · 4,728 grant · 4,110 device 510k · 3,288 8k filing · 3,118 approval · 2,000 device pma · 2,000 device recall
21,882 catalysts · 4,728 grant · 4,110 device 510k · 3,288 8k filing · 3,118 approval · 2,000 device pma · 2,000 device recall
Voriconazole Container Description: voriconazole The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping. — Reason: CGMP Deviations — Status: Ongoing
Product code: SEW. Advisory committee: General Hospital. Type: Direct
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Special
Product code: QAI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: MQB. Advisory committee: Radiology. Type: Special
Product code: IYE. Advisory committee: Radiology. Type: Traditional
Product code: ODC. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Special
Product code: MNR. Advisory committee: Anesthesiology. Type: Traditional
Product code: LZA. Advisory committee: General Hospital. Type: Special
Sponsor: IPSEN. Form: CAPSULE. Route: ORAL
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Product code: OCX. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional
Product code: DYB. Advisory committee: Cardiovascular. Type: Special
Product code: DYB. Advisory committee: Cardiovascular. Type: Traditional
Product code: MQB. Advisory committee: Radiology. Type: Special
Product code: NQQ. Advisory committee: Radiology. Type: Special
Product code: SBF. Advisory committee: Neurology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Traditional
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Special
Product code: NUC. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: OOI. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: MAX. Advisory committee: Orthopedic. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Sponsor: PFIZER. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL
Sponsor: JANSSEN PRODS. Form: TABLET. Route: ORAL
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION
Sponsor: ASTELLAS. Form: TABLET. Route: ORAL
Sponsor: ASTELLAS. Form: CAPSULE. Route: ORAL
Sponsor: Lundbeck Seattle BioPharmaceuticals, Inc.. Form: INJECTABLE. Route: INJECTION
Sponsor: Lundbeck Seattle BioPharmaceuticals, Inc.. Form: INJECTABLE. Route: INJECTION
Sponsor: ABBVIE. Form: TABLET. Route: ORAL
Product code: QFM. Advisory committee: Radiology. Type: Traditional
Product code: KDI. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: KCT. Advisory committee: General Hospital. Type: Traditional
Product code: SBF. Advisory committee: Neurology. Type: Special
Product code: QUT. Advisory committee: Microbiology. Type: Special
Product code: DRS. Advisory committee: Cardiovascular. Type: Special