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20,529 catalysts · 4,728 grant · 3,312 device 510k · 3,147 8k filing · 2,841 approval · 2,000 device pma · 2,000 device recall
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20,529 catalysts · 4,728 grant · 3,312 device 510k · 3,147 8k filing · 2,841 approval · 2,000 device pma · 2,000 device recall
Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: HARMONY. Form: TABLET. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET. Route: ORAL
Sponsor: BRISTOL-MYERS SQUIBB. Form: INJECTABLE. Route: SUBCUTANEOUS
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: QJP. Advisory committee: Cardiovascular. Type: Special
Product code: MQV. Advisory committee: Orthopedic. Type: Traditional
Product code: NFO. Advisory committee: Neurology. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OLX. Advisory committee: Neurology. Type: Traditional
Product code: DFH. Advisory committee: Immunology. Type: Traditional
Product code: PZZ. Advisory committee: Pathology. Type: Abbreviated
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: LZO. Advisory committee: Orthopedic. Type: Special
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: KWQ. Advisory committee: Orthopedic. Type: Traditional
Product code: BZD. Advisory committee: Anesthesiology. Type: Traditional
Product code: OBJ. Advisory committee: Cardiovascular. Type: Special
Product code: JKA. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: EBF. Advisory committee: Dental. Type: Traditional
Product code: IYO. Advisory committee: Radiology. Type: Traditional
Product code: HAW. Advisory committee: Neurology. Type: Traditional
Product code: FDF. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: MAI. Advisory committee: Orthopedic. Type: Traditional
Product code: QBD. Advisory committee: Microbiology. Type: Traditional
Product code: SDD. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QXJ. Advisory committee: General Hospital. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: MAI. Advisory committee: Orthopedic. Type: Special
Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: LBH. Advisory committee: Dental. Type: Traditional
Product code: EBF. Advisory committee: Dental. Type: Traditional
Product code: ODD. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: EIA. Advisory committee: Dental. Type: Traditional
Product code: GXI. Advisory committee: Neurology. Type: Traditional
Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: INJECTION
Sponsor: SANOFI-AVENTIS US. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: SANOFI-AVENTIS US. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: BOEHRINGER INGELHEIM PHARMACEUTICALS INC. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: BOEHRINGER INGELHEIM PHARMACEUTICALS INC. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS
Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-03 — Reason: CGMP Deviations — Status: Terminated
Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, packaged in a) 120-inhalation canister (NDC 0310-9080-12) b) 28-inhalation canister (NDC 0310-9080-28), Rx only, Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, By: AstraZeneca Dunkerque Production (AZDP), Dunkerque, France, Product of France, . — Reason: Defective delivery system — Status: Ongoing
Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 1.5 OZ (43 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-04 — Reason: CGMP Deviations — Status: Terminated
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 2.75 OZ (78g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-05 — Reason: CGMP Deviations — Status: Terminated