calendar
13,698 catalysts · 3,387 8k filing · 2,401 grant · 2,188 approval · 1,517 device 510k · 1,123 device recall · 1,026 device pma
next 91 dayslessmore
MonWedFri
13,698 catalysts · 3,387 8k filing · 2,401 grant · 2,188 approval · 1,517 device 510k · 1,123 device recall · 1,026 device pma
Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL
Sponsor: MSN. Form: TABLET. Route: ORAL
Product code: KNS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QKQ. Advisory committee: Pathology. Type: Traditional
Product code: OBR. Advisory committee: Unknown. Type: Traditional
Product code: PMC. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QEW. Advisory committee: Cardiovascular. Type: Traditional
Product code: LRK. Advisory committee: Dental. Type: Abbreviated
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: KPS. Advisory committee: Radiology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OAS. Advisory committee: Radiology. Type: Traditional
Product code: QQI. Advisory committee: Cardiovascular. Type: Traditional
Product code: KTT. Advisory committee: Orthopedic. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OMC. Advisory committee: Neurology. Type: Traditional
Product code: NPL. Advisory committee: Dental. Type: Traditional
Product code: MAX. Advisory committee: Orthopedic. Type: Special
Product code: IYN. Advisory committee: Radiology. Type: Special
Product code: QAS. Advisory committee: Radiology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: EBI. Advisory committee: Dental. Type: Traditional
Supplement type: Normal 180 Day Track. Product code: MRM. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MOM. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: NVN. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: LYJ. Advisory committee: NE. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: NIK. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: PNJ. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: QVG. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: PHO. Advisory committee: GU. Decision: APPR
Supplement type: Special (Immediate Track). Product code: SAW. Advisory committee: SU. Decision: APPR
Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description: Liquid adhesive, 2/3 mL vial, 48 vials per carton Component: No — Reason: Butyrate tube cracks during actuation, rendering product unusable. — Status: Ongoing
GM grant. $431,302. PI: Adrienne A Taren
Sponsor: ZYDUS LIFESCIENCES. Form: CAPSULE. Route: ORAL
Sponsor: KINDOS. Form: POWDER. Route: INTRAVENOUS
Sponsor: VIIV HLTHCARE. Form: SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR
Lantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (NDC 61924-304-05), b)14.2g (0.5 oz)( NDC 61924-304-14), c) 4oz (NDC 61924-304-04), d) 4.5oz (NDC 61924-304-45), and e) 12oz (NDC 61924-304-12) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. — Reason: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. — Status: Ongoing
KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34 — Reason: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. — Status: Ongoing
DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.18 oz) per packet (NDC 61924-234-05), and b)106 g (3.75 oz.) per tube (NDC 61924-234-04) DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. — Reason: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. — Status: Ongoing
DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08 — Reason: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. — Status: Ongoing
PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL (7.5 fl. oz.) bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08 — Reason: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. — Status: Ongoing
DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%, Net Wt. 106 g (3.75 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-214-04 — Reason: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. — Status: Ongoing
PeriGuard Ointment, Petrolatum 49.9%, packaged in a) 5g (NDC 61924-205-05), b) 3.5oz (NDC 61924-205-04), and c) 7oz (NDC 61924-205-07) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. — Reason: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. — Status: Ongoing
Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-435-04 — Reason: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. — Status: Ongoing
NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals, Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274. Packaged by GSMS, Incorporated, Carmarillo, CA 93012. NDC: 51407-268-90 — Reason: Failed Dissolution Specifications — Status: Ongoing
DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) per tube (NDC 61924-092-08), b) 800 mL (27 fl. oz.) per bag (NDC 61924-092-27), and c 1000 mL (34 fl. oz.) per bag (NDC 61924-092-34), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. — Reason: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. — Status: Ongoing
San-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-107-34 — Reason: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. — Status: Ongoing
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26 — Reason: Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq — Status: Ongoing
UltraSure Anti-Perspirant & Deodorant, Aluminum Sesquichlorohydrate 15%, 118 mL (4 fl. oz.), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-266-04 — Reason: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. — Status: Ongoing
GelRite Instant Hand Sanitizer, Alcohol 65%, packaged in a) 118 mL (NDC 61924-106-04), b) 473 mL (NDC 61924-106-16) and c) 800 mL (NDC 61924-106-27), and d) 1000 mL (NDC 61924-106-34) per container, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. — Reason: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. — Status: Ongoing