calendar
6,533 catalysts · 3,603 8k filing · 1,000 device adverse event · 773 grant · 578 earnings · 220 approval · 172 phase 2 completion
next 91 dayslessmore
MonWedFri
6,533 catalysts · 3,603 8k filing · 1,000 device adverse event · 773 grant · 578 earnings · 220 approval · 172 phase 2 completion
Product code: LOL. Advisory committee: Microbiology. Type: Traditional
Product code: HQF. Advisory committee: Ophthalmic. Type: Traditional
Product code: SEI. Advisory committee: Microbiology. Type: Traditional
Product code: SEI. Advisory committee: Microbiology. Type: Traditional
Product code: FRO. Advisory committee: Unknown. Type: Traditional
Product code: LYZ. Advisory committee: General Hospital. Type: Traditional
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: LOX. Advisory committee: Cardiovascular. Type: Traditional
Product code: SHP. Advisory committee: Cardiovascular. Type: Traditional
Product code: DYB. Advisory committee: Cardiovascular. Type: Special
Product code: FAJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Supplement type: Normal 180 Day Track No User Fee. Product code: QTL. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: DSQ. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: NOX. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: NOX. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: OZD. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: Real-Time Process. Product code: LMH. Advisory committee: SU. Decision: APPR
CA grant. $660,808. PI: Christina Vadala Angeles
AI grant. $653,742. PI: Sarah Caddy
CA grant. $696,189. PI: Nikhil Joshi
NS grant. $613,161. PI: AMY LEE
ES grant. $400,398. PI: Adam Christopher Roberts
CA grant. $403,686. PI: RUTH A. KERI
AI grant. $160,100. PI: LEE ANN Garrett-Sinha
CA grant. $586,364. PI: Jianhua Yu
GM grant. $389,203. PI: Mary K Kochlefl
AI grant. $50,114. PI: Adrianna Jones
MH grant. $793,185. PI: Guochun Jiang
AI grant. $411,078. PI: Yasmina Laouar
CA grant. $544,520. PI: Tohru Yamada
AI grant. $429,000. PI: PETER MANCUSO
EB grant. $570,612. PI: Charles F Caskey
Antiseptic wound care gel bottles and tubes
Sponsor: BIONPHARMA. Form: CAPSULE. Route: ORAL
Sponsor: HIKMA FARMACEUTICA. Form: INJECTABLE. Route: INJECTION
Sponsor: HIKMA FARMACEUTICA. Form: INJECTABLE. Route: INJECTION
Sponsor: NEUROCRINE. Form: CAPSULE. Route: ORAL
Sponsor: AIPING PHARM INC. Form: TABLET. Route: ORAL
Sponsor: CHARTWELL MOLECULAR. Form: SOLUTION. Route: ORAL
Sponsor: MICRO LABS. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Sponsor: GLENMARK PHARMS LTD. Form: INSERT. Route: VAGINAL
Sponsor: ZENARA. Form: TABLET. Route: ORAL
Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-066-11. — Reason: cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits. — Status: Ongoing
traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal Pharmaceuticals LLC, Glasgow, KY 42141, NDC 60219-2348-5. — Reason: Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH). — Status: Ongoing
Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-067-11. — Reason: cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits. — Status: Ongoing
Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, 382110, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1720-3. — Reason: Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead. — Status: Ongoing
Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0011-1; b) Good Sense, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-110-01; c) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 24385-006-05; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 09331 7; e) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., KANSAS CITY, KS 66106, UPC 0 70038 47008 3; f) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38600 7; g) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 00976 9; h) Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-189-14 — Reason: Lack of Assurance of Sterility — Status: Ongoing