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21,300 catalysts · 4,728 grant · 3,844 device 510k · 3,086 8k filing · 3,046 approval · 2,000 device pma · 2,000 device recall
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21,300 catalysts · 4,728 grant · 3,844 device 510k · 3,086 8k filing · 3,046 approval · 2,000 device pma · 2,000 device recall
Product code: JWH. Advisory committee: Orthopedic. Type: Traditional
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: OMP. Advisory committee: General, Plastic Surgery. Type: Traditional
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION
Sponsor: ELITE LABS INC. Form: TABLET. Route: ORAL
Sponsor: ASCENT PHARMS INC. Form: TABLET. Route: ORAL
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15 — Reason: Out of Specification for Dissolution — Status: Ongoing
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: QOF. Advisory committee: Microbiology. Type: Dual Track
Product code: EIA. Advisory committee: Dental. Type: Traditional
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Product code: IRP. Advisory committee: Physical Medicine. Type: Traditional
Product code: OWN. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Traditional
Product code: OWT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: KCT. Advisory committee: General Hospital. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: NGL. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: ODC. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: JDQ. Advisory committee: Orthopedic. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Product code: MQK. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: QAS. Advisory committee: Radiology. Type: Traditional
Product code: NXC. Advisory committee: Dental. Type: Traditional
Product code: JOJ. Advisory committee: General Hospital. Type: Special
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional
Product code: QHE. Advisory committee: Orthopedic. Type: Traditional
Product code: OLV. Advisory committee: Neurology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: GKZ. Advisory committee: Hematology. Type: Traditional
Sponsor: DR REDDYS LABS SA. Form: FILM. Route: BUCCAL, SUBLINGUAL
Sponsor: WATSON LABS INC. Form: TABLET. Route: ORAL
Sponsor: ZYDUS PHARMS. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM. Form: TABLET. Route: ORAL
Sponsor: CHIESI. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: PFIZER. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL
Sponsor: PFIZER. Form: SOLUTION. Route: ORAL
Sponsor: NATCO PHARMA LTD. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: AMNEAL PHARMS CO. Form: TABLET. Route: ORAL
Sponsor: PH HEALTH. Form: TABLET. Route: ORAL
Sponsor: ACTELION. Form: TABLET. Route: ORAL
Sponsor: NATCO PHARMA LTD. Form: TABLET. Route: ORAL