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21,747 catalysts · 4,728 grant · 4,110 device 510k · 3,153 8k filing · 3,118 approval · 2,000 device pma · 2,000 device recall
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21,747 catalysts · 4,728 grant · 4,110 device 510k · 3,153 8k filing · 3,118 approval · 2,000 device pma · 2,000 device recall
Sponsor: UCB INC. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: UCB INC. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: ASTRAZENECA UK LTD. Form: INJECTABLE. Route: INJECTION
Sponsor: CELLTRION INC. Form: INJECTABLE. Route: INJECTION
Sponsor: BAXTER HLTHCARE CORP. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: ALEXION PHARM. Form: INJECTABLE. Route: INJECTION
Product code: MOL. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: SAH. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DQY. Advisory committee: Cardiovascular. Type: Traditional
Product code: CAW. Advisory committee: Anesthesiology. Type: Traditional
Product code: POL. Advisory committee: Neurology. Type: Special
Product code: PSY. Advisory committee: Pathology. Type: Traditional
Product code: FPA. Advisory committee: General Hospital. Type: Traditional
Product code: KDI. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: PCH. Advisory committee: Microbiology. Type: Special
Product code: BZQ. Advisory committee: Anesthesiology. Type: Traditional
Product code: EFB. Advisory committee: Dental. Type: Traditional
Product code: PHR. Advisory committee: Dental. Type: Traditional
Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: IOR. Advisory committee: Physical Medicine. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: JWH. Advisory committee: Orthopedic. Type: Traditional
Product code: MOS. Advisory committee: Radiology. Type: Traditional
Product code: OZN. Advisory committee: Microbiology. Type: Traditional
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Product code: OUR. Advisory committee: Orthopedic. Type: Traditional
Sponsor: TARO. Form: TABLET. Route: ORAL
Sponsor: DR REDDYS. Form: TABLET. Route: ORAL
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: QAS. Advisory committee: Radiology. Type: Traditional
Product code: EOB. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: KPS. Advisory committee: Radiology. Type: Traditional
Product code: JAQ. Advisory committee: Radiology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Sponsor: ZYDUS LIFESCIENCES. Form: SOLUTION. Route: INTRAVENOUS
Product code: KTI. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: LZO. Advisory committee: Orthopedic. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Advisory committee: Unknown. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Sponsor: ARS PHARMS OPERATION. Form: SPRAY. Route: NASAL
Sponsor: GUERBET. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: BAYER HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: BAYER HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL
Sponsor: AMNEAL PHARMS NY. Form: TABLET. Route: ORAL
Sponsor: HIBROW HLTHCARE. Form: TABLET. Route: ORAL
Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30 — Reason: Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product. — Status: Completed