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18 catalysts · 14 device 510k · 3 approval · 1 recall
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18 catalysts · 14 device 510k · 3 approval · 1 recall
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