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20,411 catalysts · 4,728 grant · 3,277 8k filing · 3,163 device 510k · 2,805 approval · 2,000 device pma · 2,000 device recall
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20,411 catalysts · 4,728 grant · 3,277 8k filing · 3,163 device 510k · 2,805 approval · 2,000 device pma · 2,000 device recall
Product code: OMP. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FED. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: OVE. Advisory committee: Orthopedic. Type: Traditional
Product code: DQY. Advisory committee: Cardiovascular. Type: Traditional
Supplement type: 30-Day Notice. Product code: MKJ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: PMX. Advisory committee: SU. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: LGW. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: LNR. Advisory committee: GU. Decision: OK30
Product code: JWY. Advisory committee: Microbiology. Type: Traditional
Product code: MAX. Advisory committee: Orthopedic. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: CAF. Advisory committee: Anesthesiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Abbreviated
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: OZW. Advisory committee: General Hospital. Type: Traditional
Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION
Sponsor: RUBICON RESEARCH. Form: TABLET. Route: ORAL
Supplement type: Real-Time Process. Product code: QQK. Advisory committee: GU. Decision: APPR
Supplement type: Panel Track. Product code: NAW. Advisory committee: RA. Decision: APPR
Supplement type: Panel Track. Product code: NIP. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: QQK. Advisory committee: GU. Decision: APPR
Supplement type: 30-Day Notice. Product code: JCW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: OK30
Product code: PAB. Advisory committee: Microbiology. Type: Traditional
Product code: QRK. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LJS. Advisory committee: General Hospital. Type: Special
Product code: QBC. Advisory committee: Neurology. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Special
Product code: POK. Advisory committee: Radiology. Type: Traditional
Product code: EZD. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QFG. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: HSX. Advisory committee: Orthopedic. Type: Traditional
Product code: BSP. Advisory committee: Anesthesiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: FET. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Special
Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb, Croatia, Manufactured for Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 0093-2203-01. — Reason: Presence of foreign tablets/capsules. — Status: Ongoing
Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-2 — Reason: Lack of Assurance of Sterility — Status: Ongoing
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0578-4 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 — Reason: Lack of Assurance of Sterility — Status: Ongoing
TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscular injection only, Rx Only, ADVANCED PHARMACEUTICAL TECHNOLOGY, INC., 132 South Central Avenue, Elmsford, NY 10523. NDC 57377-200-01 — Reason: Marketed Without an Approved NDA/ANDA — Status: Ongoing
Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 — Reason: Lack of Assurance of Sterility — Status: Ongoing