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25,484 catalysts · 16,885 approval · 3,555 device 510k · 2,327 grant · 1,041 device pma · 926 device recall · 750 recall
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25,484 catalysts · 16,885 approval · 3,555 device 510k · 2,327 grant · 1,041 device pma · 926 device recall · 750 recall
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: ETB. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: QEP. Advisory committee: Microbiology. Type: Dual Track
Product code: QBS. Advisory committee: Radiology. Type: Traditional
Product code: DQK. Advisory committee: Cardiovascular. Type: Special
Product code: FTL. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FMT. Advisory committee: General Hospital. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: HAW. Advisory committee: Neurology. Type: Traditional
Product code: PAB. Advisory committee: Microbiology. Type: Special
Product code: DSA. Advisory committee: Cardiovascular. Type: Traditional
Product code: KNT. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: LDF. Advisory committee: Cardiovascular. Type: Special
Product code: LJS. Advisory committee: General Hospital. Type: Special
Product code: ETA. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: KNS. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: MQV. Advisory committee: Orthopedic. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Abbreviated
Product code: KPS. Advisory committee: Radiology. Type: Traditional
Product code: HGP. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: SDX. Advisory committee: Neurology. Type: Direct
Product code: QJP. Advisory committee: Cardiovascular. Type: Traditional
Product code: JOJ. Advisory committee: General Hospital. Type: Traditional
Product code: LJS. Advisory committee: General Hospital. Type: Traditional
Sponsor: KYOWA KIRIN. Form: INJECTABLE. Route: INJECTION
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTION. Route: SOLUTION
Sponsor: SPROUT PHARMS. Form: TABLET. Route: ORAL
Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Special
Product code: NUC. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: FBN. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QHE. Advisory committee: Orthopedic. Type: Special
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Sponsor: AIPING PHARM INC. Form: TABLET. Route: ORAL
Sponsor: AUROBINDO PHARMA LTD. Form: CAPSULE. Route: ORAL
Sponsor: CHEPLAPHARM. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL
Sponsor: CHEPLAPHARM. Form: SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR
Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL
Sponsor: CHEPLAPHARM. Form: POWDER. Route: INTRAMUSCULAR
Sponsor: ALKERMES INC. Form: TABLET. Route: ORAL
Sponsor: OTSUKA PHARM CO LTD. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR
Sponsor: SHANDONG LUYE. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR
Sponsor: GLENMARK PHARMS LTD. Form: CAPSULE. Route: ORAL
Sponsor: GLENMARK PHARMS LTD. Form: CAPSULE. Route: ORAL
Sponsor: ASTELLAS. Form: TABLET. Route: ORAL
Sponsor: ASTELLAS. Form: CAPSULE. Route: ORAL
Sponsor: JANSSEN PHARMS. Form: INJECTABLE. Route: INJECTION
Sponsor: TEVA. Form: SUSPENSION, EXTENDED RELEASE. Route: SUBCUTANEOUS
glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC: 60687-480-21, Unit Dose NDC: 60687-480-11 — Reason: Failed Dissolution Specifications: — Status: Terminated
Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-8014-01. — Reason: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. — Status: Ongoing