calendar
20,452 catalysts · 4,728 grant · 3,305 device 510k · 3,085 8k filing · 2,833 approval · 2,000 device pma · 2,000 device recall
next 91 dayslessmore
MonWedFri
20,452 catalysts · 4,728 grant · 3,305 device 510k · 3,085 8k filing · 2,833 approval · 2,000 device pma · 2,000 device recall
Teriflunomide Tablets, 14mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-424-30 — Reason: CGMP Deviations — Status: Ongoing
Fluphenazine Hydrochloride Tablets 2.5mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-336-01 — Reason: CGMP Deviations — Status: Ongoing
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Special
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: IZF. Advisory committee: Radiology. Type: Traditional
Product code: PBX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LEL. Advisory committee: Neurology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION
Product code: PLQ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: EZD. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: QER. Advisory committee: Ophthalmic. Type: Traditional
Product code: QDG. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: JWH. Advisory committee: Orthopedic. Type: Special
Product code: OBP. Advisory committee: Neurology. Type: Traditional
Product code: SEM. Advisory committee: Neurology. Type: Direct
Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional
Product code: OCW. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional
Product code: MUJ. Advisory committee: Radiology. Type: Traditional
Product code: OAS. Advisory committee: Radiology. Type: Traditional
Product code: DQY. Advisory committee: Cardiovascular. Type: Traditional
Product code: QCI. Advisory committee: Neurology. Type: Traditional
Sponsor: ASTRAZENECA AB. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: AMGEN INC. Form: INJECTABLE. Route: INJECTION
Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL
Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION
Product code: DCK. Advisory committee: Immunology. Type: Traditional
Product code: PKL. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: IZL. Advisory committee: Radiology. Type: Traditional
Product code: FMI. Advisory committee: General Hospital. Type: Traditional
Product code: NGX. Advisory committee: Physical Medicine. Type: Traditional
Product code: MQB. Advisory committee: Radiology. Type: Special
Product code: PSZ. Advisory committee: Microbiology. Type: Dual Track
Product code: ONE. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LZO. Advisory committee: Orthopedic. Type: Special
Product code: KPE. Advisory committee: General Hospital. Type: Traditional
Product code: PEN. Advisory committee: Microbiology. Type: Traditional
Product code: DXZ. Advisory committee: Cardiovascular. Type: Traditional
Product code: PIF. Advisory committee: Gastroenterology, Urology. Type: Traditional
Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: NOVARTIS. Form: TABLET. Route: ORAL
Product code: DYW. Advisory committee: Dental. Type: Traditional
Product code: MOF. Advisory committee: Cardiovascular. Type: Traditional
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Abbreviated
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional