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1,094 catalysts · 3,288 8k filing · 2,037 grant · 1,000 device adverse event · 923 approval · 688 device 510k · 584 earnings
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1,094 catalysts · 3,288 8k filing · 2,037 grant · 1,000 device adverse event · 923 approval · 688 device 510k · 584 earnings
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Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL
Sponsor: PF PRISM CV. Form: POWDER. Route: INTRAVENOUS
Sponsor: PF PRISM CV. Form: FOR SUSPENSION. Route: ORAL
Sponsor: HIKMA. Form: SOLUTION. Route: ORAL
Sponsor: HIKMA. Form: SOLUTION. Route: ORAL
Sponsor: VISUS. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Sponsor: LUPIN LTD. Form: TABLET. Route: ORAL
Sponsor: MYLAN INSTITUTIONAL. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: TARO. Form: CAPSULE. Route: ORAL
Sponsor: OTSUKA PHARM CO LTD. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR
Sponsor: AMNEAL. Form: CAPSULE. Route: ORAL
Sponsor: UNICHEM. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: UNICHEM. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39 — Reason: Failed PH Specifications — Status: Ongoing
Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07 — Reason: Subpotent Drug: Due oxidation caused by leakage of the contents of the Icosapent Ethyl 1g capsules. Use of the affected product may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients. — Status: Ongoing
Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., East Brunswick, NJ 08816, Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, India, NDC 64980-563-10. — Reason: Presence of Foreign Substance — Status: Ongoing
Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-100-02 — Reason: Subpotent Drug — Status: Ongoing
Sponsor: NOVO. Form: TABLET. Route: ORAL
Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: GENSCO. Form: FILM. Route: ORAL
Sponsor: ZYDUS LIFESCIENCES. Form: CAPSULE. Route: ORAL
Sponsor: RISING. Form: CAPSULE. Route: ORAL
Sponsor: SOMERSET THERAPS LLC. Form: TABLET. Route: ORAL
Sponsor: REGCON HOLDINGS. Form: SOLUTION. Route: ORAL
Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: ACTAVIS ELIZABETH. Form: CAPSULE. Route: ORAL
Sponsor: JOURNEY. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: PFIZER. Form: TABLET. Route: ORAL
Sponsor: ZYDUS LIFESCIENCES. Form: TABLET. Route: ORAL
Sponsor: CHEPLAPHARM. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL
Sponsor: SUNSHINE. Form: TABLET. Route: ORAL
Sponsor: SUNSHINE. Form: TABLET. Route: ORAL
Sponsor: CHEPLAPHARM. Form: SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR
Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION
Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL
Sponsor: EUGIA PHARMA. Form: INJECTABLE. Route: INJECTION
Sponsor: CIPLA LTD. Form: INJECTABLE. Route: INJECTION
Sponsor: HIKMA PHARMS. Form: FOR SUSPENSION. Route: ORAL
Sponsor: PH HEALTH. Form: CAPSULE. Route: ORAL
Sponsor: GILEAD SCIENCES INC. Form: CAPSULE. Route: ORAL
Sponsor: EPIC PHARMA LLC. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Sponsor: EPIC PHARMA LLC. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Sponsor: EPIC PHARMA LLC. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Sponsor: APOTEX. Form: TABLET. Route: ORAL
Sponsor: CHEPLAPHARM. Form: POWDER. Route: INTRAMUSCULAR
Sponsor: ALEMBIC. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET, FOR SUSPENSION. Route: ORAL