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23,077 catalysts · 4,900 device 510k · 4,728 grant · 3,532 approval · 3,126 8k filing · 2,000 device pma · 2,000 device recall
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23,077 catalysts · 4,900 device 510k · 4,728 grant · 3,532 approval · 3,126 8k filing · 2,000 device pma · 2,000 device recall
Product code: GXH. Advisory committee: Neurology. Type: Special
Product code: MBI. Advisory committee: Orthopedic. Type: Special
Product code: PLO. Advisory committee: Microbiology. Type: Traditional
Product code: HWC. Advisory committee: Orthopedic. Type: Traditional
Product code: MBH. Advisory committee: Orthopedic. Type: Special
Product code: JAQ. Advisory committee: Radiology. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: NWA. Advisory committee: General, Plastic Surgery. Type: Special
Product code: OVD. Advisory committee: Orthopedic. Type: Traditional
Sponsor: TG THERAPEUTICS, INC. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: ABLYNX NV. Form: INJECTABLE. Route: INJECTION
Sponsor: OSMOTICA PHARM US. Form: TABLET, EXTENDED RELEASE. Route: ORAL
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58 — Reason: cGMP violations — Status: Terminated
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58 — Reason: cGMP violations — Status: Terminated
EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58 — Reason: cGMP violations — Status: Terminated
Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59 — Reason: cGMP violations — Status: Terminated
AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg, — Reason: Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen. — Status: Ongoing
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58 — Reason: cGMP violations — Status: Terminated
OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., Fairfield, NJ 07004, NDC 71399-0039-06. — Reason: CGMP Deviations — Status: Ongoing
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58 — Reason: cGMP violations — Status: Terminated
Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56 — Reason: cGMP violations — Status: Terminated
Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58 — Reason: cGMP violations — Status: Terminated
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58 — Reason: CGMP violations — Status: Terminated
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58 — Reason: cGMP violations — Status: Terminated
Product code: QHH. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: FCX. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: DSI. Advisory committee: Cardiovascular. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: QNA. Advisory committee: Gastroenterology, Urology. Type: Direct
Product code: KPS. Advisory committee: Radiology. Type: Special
Product code: DKZ. Advisory committee: Clinical Toxicology. Type: Special
Product code: FLL. Advisory committee: General Hospital. Type: Traditional
Product code: HSX. Advisory committee: Orthopedic. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: QGM. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FMK. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: SBF. Advisory committee: Neurology. Type: Traditional
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Sponsor: STRIDES PHARMA. Form: TABLET. Route: ORAL
Sponsor: AMNEAL. Form: INJECTABLE. Route: INJECTION
Sponsor: UNICHEM. Form: TABLET. Route: ORAL
Sponsor: LUPIN. Form: TABLET. Route: ORAL
Sponsor: VISTAPHARM LLC. Form: SOLUTION. Route: ORAL
Sponsor: NOVEL LABS INC. Form: TABLET. Route: ORAL
Sponsor: NOVEL LABS INC. Form: TABLET. Route: ORAL
Sponsor: HIKMA. Form: SOLUTION. Route: ORAL
Sponsor: VISTAPHARM LLC. Form: SOLUTION. Route: ORAL
Sponsor: NOVEL LABS INC. Form: SOLUTION. Route: ORAL
Sponsor: ACTAVIS ELIZABETH. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: LGM PHARMA. Form: TABLET. Route: ORAL