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4,219 catalysts · 3,124 8k filing · 576 earnings · 172 phase 2 completion · 169 grant · 133 drug shortage · 121 approval
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4,219 catalysts · 3,124 8k filing · 576 earnings · 172 phase 2 completion · 169 grant · 133 drug shortage · 121 approval
AI grant. $403,756. PI: Joseph Thomas Wade
EB grant. $381,392. PI: Jicheng Fu
EB grant. $616,375. PI: Eugene Thomas Pashuck
ES grant. $1,460,280. PI: Chuanxi Cai
AI grant. $196,020. PI: Alyssa K Mezochow
CA grant. $40,000. PI: Michael E. Scheurer
Sponsor: TEVA PHARMS INC. Form: LIQUID. Route: ORAL
Sponsor: BIOCODEX SA. Form: CAPSULE. Route: ORAL
Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION
Sponsor: AUROBINDO PHARMA. Form: TABLET. Route: ORAL
Sponsor: ONESOURCE SPECIALTY. Form: INJECTABLE. Route: INJECTION
Sponsor: ALEMBIC. Form: INJECTABLE. Route: INJECTION
Sponsor: ONESOURCE SPECIALTY. Form: INJECTABLE. Route: INJECTION
Sponsor: ASTRAZENECA AB. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: AUROBINDO PHARMA. Form: LIQUID
Sponsor: MICRO LABS. Form: TABLET. Route: ORAL
Sponsor: IPCA LABS LTD. Form: TABLET. Route: ORAL
Sponsor: ASPIRO. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: MSN. Form: LIQUID. Route: ORAL
Sponsor: AUROBINDO PHARMA LTD. Form: SUSPENSION, EXTENDED RELEASE. Route: ORAL
Sponsor: BIOCODEX SA. Form: FOR SUSPENSION. Route: ORAL
Sponsor: MYLAN LABS LTD. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: EDENBRIDGE PHARMS. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Sponsor: OXFORD PHARMS. Form: TABLET. Route: ORAL
Sponsor: IMPAX LABS. Form: TABLET. Route: ORAL
Sponsor: IMPAX LABS. Form: TABLET. Route: ORAL
Sponsor: IMPAX LABS. Form: TABLET. Route: ORAL
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: POWDER. Route: IV (INFUSION)
Sponsor: BAXTER HLTHCARE CORP. Form: INJECTABLE. Route: INJECTION
Sponsor: DR REDDYS LABS SA. Form: FILM. Route: BUCCAL, SUBLINGUAL
Sponsor: DR REDDYS LABS SA. Form: FILM. Route: BUCCAL, SUBLINGUAL
Sponsor: DR REDDYS LABS SA. Form: FILM. Route: BUCCAL, SUBLINGUAL
Sponsor: DR REDDYS LABS SA. Form: FILM. Route: BUCCAL, SUBLINGUAL
Sponsor: DR REDDYS LABS SA. Form: FILM. Route: BUCCAL, SUBLINGUAL
Sponsor: DR REDDYS LABS SA. Form: FILM. Route: BUCCAL, SUBLINGUAL
Sponsor: DR REDDYS LABS SA. Form: FILM. Route: BUCCAL, SUBLINGUAL
Sponsor: GE HLTHCARE INC. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: GENENTECH INC. Form: TABLET. Route: ORAL
Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01 — Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port — Status: Ongoing
0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-470-05, Unit of Sale NDC Number: 65219-470-30. — Reason: Lack of Assurance of Sterility — Status: Ongoing
0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case). — Reason: Lack of Assurance of Sterility — Status: Ongoing
Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3509-04 carton, NDC 0591-3509-54 pouch — Reason: CGMP Deviations: use of an unapproved raw material — Status: Ongoing
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of Use NDC: 65219-432-20, Unit of Sale NDC Number: 65219-432-85. — Reason: Lack of Assurance of Sterility — Status: Ongoing
0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 600047, Unit of Use NDC: 65219-468-05, Unit of Sale NDC Number: 65219-468-50. — Reason: Lack of Assurance of Sterility — Status: Ongoing
0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20. — Reason: Lack of Assurance of Sterility — Status: Ongoing
Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx Only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3508-04 carton, NDC 0591-3508-54 pouch — Reason: CGMP Deviations: use of an unapproved raw material — Status: Ongoing
Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5083-01 — Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port — Status: Ongoing
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-03. — Reason: Lack of Assurance of Sterility — Status: Ongoing
GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91. — Reason: Presence of particulate matter — Status: Ongoing