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21,871 catalysts · 4,728 grant · 4,110 device 510k · 3,277 8k filing · 3,118 approval · 2,000 device pma · 2,000 device recall
21,871 catalysts · 4,728 grant · 4,110 device 510k · 3,277 8k filing · 3,118 approval · 2,000 device pma · 2,000 device recall
Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02 — Reason: Presence of foreign substance: Presence of Benzene. — Status: Ongoing
Product code: JXI. Advisory committee: Neurology. Type: Traditional
Product code: FRN. Advisory committee: General Hospital. Type: Traditional
Product code: QFG. Advisory committee: Clinical Chemistry. Type: Special
Product code: JWH. Advisory committee: Orthopedic. Type: Special
Product code: LOD. Advisory committee: Orthopedic. Type: Special
Product code: FRN. Advisory committee: General Hospital. Type: Traditional
Product code: QNQ. Advisory committee: General Hospital. Type: Traditional
Product code: HDR. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: NUH. Advisory committee: Neurology. Type: Traditional
Product code: FET. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: JXI. Advisory committee: Neurology. Type: Traditional
Product code: KNF. Advisory committee: Obstetrics/Gynecology. Type: Special
Product code: PHC. Advisory committee: General Hospital. Type: Traditional
Product code: HWC. Advisory committee: Orthopedic. Type: Special
Product code: DQX. Advisory committee: Cardiovascular. Type: Special
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Special
Sponsor: SPECGX LLC. Form: TABLET. Route: ORAL
Sponsor: WES PHARMA INC. Form: TABLET. Route: ORAL
Sponsor: VIELA BIO. Form: INJECTABLE. Route: INJECTION
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: KDJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: FMI. Advisory committee: General Hospital. Type: Special
Product code: HQF. Advisory committee: Ophthalmic. Type: Traditional
Product code: MAI. Advisory committee: Orthopedic. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: QLY. Advisory committee: General Hospital. Type: Special
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: DPS. Advisory committee: Cardiovascular. Type: Traditional
Sponsor: CUBIST PHARMS LLC. Form: TABLET. Route: ORAL
Sponsor: CUBIST PHARMS LLC. Form: POWDER. Route: INTRAVENOUS
Sponsor: WATSON LABS INC. Form: TABLET. Route: ORAL
Sponsor: SIGMAPHARM LABS LLC. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM. Form: TABLET. Route: ORAL
Sponsor: APOTEX. Form: TABLET. Route: ORAL
Product code: LIT. Advisory committee: Cardiovascular. Type: Special
Product code: OLP. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: BZQ. Advisory committee: Anesthesiology. Type: Traditional
Product code: QEZ. Advisory committee: Cardiovascular. Type: Traditional
Product code: QJU. Advisory committee: Radiology. Type: Traditional
Product code: FMI. Advisory committee: General Hospital. Type: Traditional
Product code: NKG. Advisory committee: Orthopedic. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Special
Product code: FRG. Advisory committee: General Hospital. Type: Traditional
Product code: JSM. Advisory committee: Microbiology. Type: Traditional
Product code: QVY. Advisory committee: General Hospital. Type: Direct
Product code: PTC. Advisory committee: Clinical Chemistry. Type: Traditional