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7,405 catalysts · 3,350 8k filing · 1,080 grant · 1,000 device adverse event · 579 earnings · 519 approval · 408 device 510k
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7,405 catalysts · 3,350 8k filing · 1,080 grant · 1,000 device adverse event · 579 earnings · 519 approval · 408 device 510k
Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), Teva Pharmaceuticals, Parsippany, NJ 07054. — Reason: Failed Dissolution Specifications — Status: Ongoing
Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium Chloride 0.13%), 1000 per case, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00 — Reason: CGMP Deviations — Status: Ongoing
SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China — Reason: Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam. — Status: Ongoing
Product code: FRO. Advisory committee: Unknown. Type: Traditional
Product code: PHX. Advisory committee: Orthopedic. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Traditional
Product code: EBF. Advisory committee: Dental. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: DWF. Advisory committee: Cardiovascular. Type: Traditional
Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: IZL. Advisory committee: Radiology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPW. Advisory committee: CV. Decision: OK30
Supplement type: Panel Track. Product code: HQL. Advisory committee: OP. Decision: APPR
Supplement type: 30-Day Notice. Product code: NPT. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPU. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: DYE. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: PJQ. Advisory committee: CV. Decision: OK30
EB grant. $72,965. PI: Lesley W Chow
CA grant. $668,691. PI: Gretchen Kimmick
NS grant. $553,292. PI: Jonathan M. Grasman
CA grant. $646,920. PI: Ryan A Wilcox
HL grant. $43,560. PI: Stephanie Armbruster
EB grant. $597,977. PI: Zheng Yan
GM grant. $105,987. PI: Janet Iwasa
GM grant. $225,000. PI: Jacob T Mey
Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION
Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION
Sponsor: HETERO LABS LTD III. Form: SYRUP. Route: ORAL
Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: INJECTION
Sponsor: SANOFI-AVENTIS US. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: CAPLIN. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: BIOCON LTD. Form: CAPSULE. Route: ORAL
Sponsor: BIOCON LTD. Form: CAPSULE. Route: ORAL
Sponsor: SANOFI-AVENTIS US. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: GILEAD SCIENCES INC. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: GILEAD SCIENCES INC. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: CAPSULE. Route: ORAL
Product code: CBK. Advisory committee: Anesthesiology. Type: Traditional
Product code: KRA. Advisory committee: Cardiovascular. Type: Traditional
Product code: GXY. Advisory committee: Neurology. Type: Special
Product code: KTI. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: EHD. Advisory committee: Dental. Type: Traditional
Product code: EZD. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Abbreviated