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23,207 catalysts · 4,956 device 510k · 4,728 grant · 3,543 approval · 3,189 8k filing · 2,000 device pma · 2,000 device recall
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23,207 catalysts · 4,956 device 510k · 4,728 grant · 3,543 approval · 3,189 8k filing · 2,000 device pma · 2,000 device recall
Sponsor: IMPAX. Form: INJECTABLE. Route: INTRAMUSCULAR, SUBCUTANEOUS
Sponsor: SANALUZ. Form: TABLET. Route: ORAL
Sponsor: SANALUZ. Form: TABLET. Route: ORAL
Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, Distributed by: MAJOR Pharmaceuticals, Livonia, MI, 48152, USA, NDC 0904-6441-61. — Reason: Failed Impurities/Degradation Specifications; during routine stability testing for impurities. — Status: Terminated
Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98 — Reason: Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets. — Status: Ongoing
Trinity Gold Nutrition, 60 Capsule, 30 day Supply, Distributed by Trinity Gold Nutrition 201 Tom Hall St. Ste. 2107, Fortmill, SC 29716, USA, Ph: 704-629-8203, www.trinitygold.com, Made in India, UPC 802992001009 — Reason: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone. — Status: Ongoing
Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt. 10 oz. (283.5 g) pumps, Mint flavor, Manufactured by: Keystone Industries, 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC 68400-202-10 — Reason: Subpotent Drug — Status: Ongoing
Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Exelan Pharmaceuticals, NDC 76282-0478-90 — Reason: Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets. — Status: Ongoing
Product code: PKC. Advisory committee: Orthopedic. Type: Traditional
Product code: NGL. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: MBB. Advisory committee: Orthopedic. Type: Traditional
Product code: QNQ. Advisory committee: General Hospital. Type: Traditional
Product code: DYB. Advisory committee: Cardiovascular. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: PBX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OVE. Advisory committee: Orthopedic. Type: Traditional
Product code: EIH. Advisory committee: Dental. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: IRP. Advisory committee: Physical Medicine. Type: Traditional
Product code: BZG. Advisory committee: Anesthesiology. Type: Traditional
Product code: QJP. Advisory committee: Cardiovascular. Type: Traditional
Product code: OAP. Advisory committee: Physical Medicine. Type: Traditional
Sponsor: IBSA INST BIO. Form: SYSTEM. Route: TOPICAL
Sponsor: CUMBERLAND PHARMS. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: AUROBINDO PHARMA USA. Form: TABLET, DELAYED RELEASE. Route: ORAL
Sponsor: AVION PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: ORAL
Sponsor: STEVENS J. Form: CAPSULE. Route: ORAL
Sponsor: BARR LABS INC. Form: TABLET. Route: ORAL
Sponsor: STRIDES PHARMA. Form: TABLET. Route: ORAL
Sponsor: ENDO OPERATIONS. Form: TABLET. Route: ORAL
Sponsor: ANI PHARMS. Form: TABLET. Route: ORAL
Sponsor: NOVITIUM PHARMA. Form: CAPSULE. Route: ORAL
Sponsor: ACTAVIS LABS FL INC. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM INDUSTRIES. Form: CAPSULE. Route: ORAL
Sponsor: SUN PHARM INDS INC. Form: TABLET. Route: ORAL
Sponsor: AMNEAL PHARMS NY. Form: TABLET. Route: ORAL
Sponsor: AUROLIFE PHARMA LLC. Form: TABLET. Route: ORAL
Sponsor: INGENUS PHARMS NJ. Form: TABLET. Route: ORAL
Product code: CBF. Advisory committee: Anesthesiology. Type: Traditional
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: MBP. Advisory committee: Orthopedic. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MQB. Advisory committee: Radiology. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: PBX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OUR. Advisory committee: Orthopedic. Type: Traditional
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Product code: EZD. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional