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22,704 catalysts · 4,728 grant · 4,646 device 510k · 3,312 8k filing · 3,239 approval · 2,000 device pma · 2,000 device recall
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22,704 catalysts · 4,728 grant · 4,646 device 510k · 3,312 8k filing · 3,239 approval · 2,000 device pma · 2,000 device recall
Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code# 850015736018 — Reason: Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles. — Status: Ongoing
Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01. — Reason: Failed Impurities/Degradation Specification — Status: Ongoing
Product code: CBK. Advisory committee: Anesthesiology. Type: Traditional
Product code: EIH. Advisory committee: Dental. Type: Traditional
Product code: EFB. Advisory committee: Dental. Type: Traditional
Product code: SDG. Advisory committee: Neurology. Type: Direct
Product code: FRO. Advisory committee: Unknown. Type: Special
Product code: OPP. Advisory committee: General Hospital. Type: Special
Product code: OLK. Advisory committee: Cardiovascular. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Sponsor: EISAI INC. Form: INJECTABLE. Route: INJECTION
Product code: IRP. Advisory committee: Physical Medicine. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: ONF. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MSX. Advisory committee: Cardiovascular. Type: Traditional
Product code: PBX. Advisory committee: General, Plastic Surgery. Type: Special
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: CAH. Advisory committee: Anesthesiology. Type: Traditional
Product code: POK. Advisory committee: Radiology. Type: Traditional
Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTION. Route: SOLUTION
Sponsor: SYNDAX. Form: TABLET. Route: ORAL
Product code: OTM. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QOF. Advisory committee: Microbiology. Type: Traditional
Product code: ELW. Advisory committee: Dental. Type: Traditional
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: QFM. Advisory committee: Radiology. Type: Traditional
Product code: POK. Advisory committee: Radiology. Type: Traditional
Product code: DSY. Advisory committee: Cardiovascular. Type: Traditional
Product code: QRL. Advisory committee: General, Plastic Surgery. Type: Special
Product code: LLZ. Advisory committee: Radiology. Type: Abbreviated
Product code: LIT. Advisory committee: Cardiovascular. Type: Traditional
Product code: SDJ. Advisory committee: Cardiovascular. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: MQB. Advisory committee: Radiology. Type: Traditional
Advisory committee: Unknown. Type: Traditional
Product code: MQE. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: LZO. Advisory committee: Orthopedic. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Special
Product code: NLH. Advisory committee: Cardiovascular. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QME. Advisory committee: Cardiovascular. Type: Traditional
Product code: DTM. Advisory committee: Cardiovascular. Type: Special
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: MQV. Advisory committee: Orthopedic. Type: Special