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1,233 catalysts · 3,332 8k filing · 2,052 grant · 1,029 approval · 1,000 device adverse event · 743 device 510k · 584 earnings
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1,233 catalysts · 3,332 8k filing · 2,052 grant · 1,029 approval · 1,000 device adverse event · 743 device 510k · 584 earnings
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Sponsor: GLENMARK PHARMS LTD. Form: CAPSULE. Route: ORAL
Sponsor: SUN PHARM. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM. Form: TABLET. Route: ORAL
Sponsor: MYLAN. Form: TABLET. Route: ORAL
Sponsor: AMTA. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: HQ SPECLT PHARMA. Form: INJECTABLE. Route: INJECTION
Sponsor: HQ SPECLT PHARMA. Form: INJECTABLE. Route: INJECTION
Sponsor: SUN PHARM INDS LTD. Form: TABLET. Route: ORAL
Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL
Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: ALKEM LABS LTD. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: ORAL
Sponsor: BAUSCH AND LOMB. Form: GEL. Route: OPHTHALMIC
Sponsor: UMEDICA. Form: CAPSULE. Route: ORAL
Sponsor: HIKMA INTL PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: HIKMA INTL PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: NOVITIUM PHARMA. Form: CAPSULE. Route: ORAL
Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION
Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION
Sponsor: APOTEX. Form: TABLET. Route: ORAL
Sponsor: SOMERSET THERAPS LLC. Form: TABLET. Route: ORAL
Sponsor: APPCO. Form: CAPSULE. Route: ORAL
Sponsor: GENENTECH INC. Form: TABLET. Route: ORAL
Sponsor: GENENTECH INC. Form: FOR SOLUTION. Route: ORAL
Sponsor: GENENTECH INC. Form: FOR SOLUTION. Route: ORAL
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: MSD. Form: TABLET. Route: ORAL
Sponsor: GLENMARK PHARMS. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL
Sponsor: TWI PHARMS. Form: EMULSION. Route: OPHTHALMIC
Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: CELLTRION INC. Form: INJECTABLE. Route: IV (INFUSION)
Sponsor: HISUN PHARM HANGZHOU. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: ASCENT PHARMS INC. Form: FILM. Route: BUCCAL, SUBLINGUAL
TYLENOL a) 500 MG., 2'S DISPLAY, 50CT; b) COLD & FLU, 25CT/2S; c) COLD & FLU SEVERE, 2PK, 50CT; d) PM, 50CT; e) SINUS SEVERE, 2PK, 50CT — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
LIQUID DAYQUIL 12/8oz — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
EXCEDRIN MIGRAINE 2'S- 25 CT — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Swan, White Clear Alcohol, 50%, 16oz, 12 count — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Personal Care, Vaporizing Chest Rub, 4 oz, 12 count, UPC 048155903319 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Petroleum jelly: a) Vaseline Petroleum Jelly, 1.75, 12CT, UPC: 6001085120946; b) Vaseline Men Cooling Petroleum Jelly, 100ML, 12CT, UPC: 60022141; c) Vaseline Vitamin E, Petroleum Jelly, 100ML, 12CT, UPC: 6001085121028; MEN FRESH PETROLEUM JELLY, 100ML, 12CT, UPC: 60022127; d) Lucky Petroleum Jelly, 6 OZ, 12 PK, UPC: 808829081466;048155903562; e) Lucky Petroleum Jelly, COCOA, 6oz, 12ct, UPC: 808829081572, 048155922150; f) Personal Care, CREAMY PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155908642; g) Personal Care, CREAMY COCOA PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155922242; h) SOFTEE, PETROLEUM JELLY, 5oz, 12CT, UPC: 096002007208 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Aleve 1's, 60 CT — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
TUMS a) Assorted, 12 Ct.; b) Extra Strength (EX) Assorted Berries, 12-count #1194A *05/27; c)Extra Strength (EX) Assorted Fruit, 12-count, #1194C *03/27 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
MOTRIN 2'S DISP.- 50CT — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
LUCKY ICE, Cool Mouthwash, Alcohol Free, 16.9oz, 12CT, UPC: 808829108989 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Personal Care, Ice Gel, 8oz, 12 count, UPC 048155903463 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
EXCEDRIN 2'S DISP.- 30 CT — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Toothpaste: a) COLGATE, TOOTHPASTE, WHITENING, 2.5oz, 24ct; UPC: 035000511065; b) COLGATE, TOOTHPASTE, Regular, 2.5oz, 24ct, UPC: 035000511058; c) COLGATE, TOOTHPASTE, TRIPLE, 2.5oz, 24ct, UPC: 035000512109; d) COLGATE, TOOTHPASTE, MINT ZING, 24CT, 2.5oz, UPC: 035000744609; COLGATE, MAXFRESH, SPICY FRESH, RED TOOTH PASTE, 72CT, 150G; e) CREST, TOOTHPASTE, 40CT, 8.2OZ, UPC: 037000247081 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4 — Reason: Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D. — Status: Ongoing
Deodorant: a) Axe, Body Spray, Wild Spice, 6CT, 150ML, UPC: 600108736469; b) LUCKY MENS STICK DEODORANT, SPRING FRESH, 24CT, 2.5 OZ, UPC: 808829111668; c) LUCKY MENS STICK DEODORANT, FRESH COMFORT, 24CT, 1.6 OZ, UPC: 808829089103; d) LADY DEODORANT, CHERRY BLOSSOSM, 24CT, 1.8oz, UPC: 048155921092; e) AXE, BODY SPRAY, APOLLO, 6CT, 150ML; f) AXE, BODY SPRAY, BLACK, 6CT, 150ML; g) AXE, BODY SPRAY, DARK TEMPTATION, 6CT, 150ML; h) AXE, BODY SPRAY, GOLD, 6CT, 150ML; i) AXE, BODY SPRAY, EXCITE, 6CT, 150ML; j) AXE, BODY SPRAY, ICE CHILL, 6CT, 150ML; k) AXE, BODY SPRAY, MUSK, 6CT, 150ML; l) AXE, DEODORANT SPRAY, ADRENALIN, 6CT, 150ML — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
CHILDREN NYQUIL, COLD&FLU, BERRY, 8oz, 12ct — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing