calendar
987 catalysts · 3,045 8k filing · 1,751 grant · 1,000 device adverse event · 820 approval · 632 device 510k · 579 earnings
987 catalysts · 3,045 8k filing · 1,751 grant · 1,000 device adverse event · 820 approval · 632 device 510k · 579 earnings
no tagged catalysts yet
Sponsor: ACCORD HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: QILU PHARM HAINAN. Form: INJECTABLE. Route: INTRAVENOUS
parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL), Distributed by Haleon, Warren, NJ 07059. NDC 0135-0651-02 — Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles. — Status: Ongoing
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02. — Reason: Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution — Status: Ongoing
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway, NJ 08854, Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854, NDC 72205-070-72 — Reason: Failed Impurities/Degradation Specifications — Status: Ongoing
methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977. NDC 59762-4440-2 — Reason: Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil. — Status: Ongoing
INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01 — Reason: Failed Disintegration Specifications: above the time expected. — Status: Ongoing
Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION
Sponsor: SAGENT PHARMS INC. Form: INJECTABLE. Route: INJECTION
Sponsor: SAGENT PHARMS INC. Form: INJECTABLE. Route: INJECTION
Sponsor: KINDOS. Form: INJECTABLE. Route: INJECTION
Sponsor: P AND L. Form: GUM, CHEWING. Route: BUCCAL
Sponsor: STERANCO HLTHCARE. Form: SUSPENSION. Route: ORAL
Sponsor: KINDOS. Form: INJECTABLE. Route: INJECTION
Sponsor: MSN. Form: TABLET. Route: ORAL
Sponsor: ACCORD HLTHCARE. Form: INJECTABLE. Route: INJECTION
Sponsor: EUGIA PHARMA SPECLTS. Form: INJECTABLE. Route: INJECTION
Sponsor: EUGIA PHARMA SPECLTS. Form: INJECTABLE. Route: INJECTION
Sponsor: TEVA PHARMS INC. Form: TABLET. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET. Route: ORAL
Sponsor: CYTOKINETICS. Form: TABLET. Route: ORAL
Sponsor: ACCORD HLTHCARE. Form: INJECTABLE. Route: INJECTION
Sponsor: APOTEX. Form: INJECTABLE. Route: INJECTION
Sponsor: NOVAST LABS. Form: INJECTABLE. Route: INJECTION
Sponsor: ALEMBIC. Form: INJECTABLE. Route: INJECTION
Sponsor: NOVAST LABS. Form: INJECTABLE. Route: INJECTION
Sponsor: GLAND. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: ALEMBIC. Form: INJECTABLE. Route: INJECTION
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION
Sponsor: BARR LABS. Form: CAPSULE. Route: ORAL
Sponsor: EPIC PHARMA LLC. Form: CAPSULE. Route: ORAL
Sponsor: PH HEALTH. Form: TABLET. Route: ORAL
Sponsor: PFIZER. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: SENORES PHARMS. Form: TABLET. Route: ORAL
Sponsor: MANKIND PHARMA. Form: TABLET. Route: ORAL
Sponsor: BAXTER HLTHCARE CORP. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL
Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL
Sponsor: ANI PHARMS. Form: TABLET. Route: ORAL
Sponsor: ACTAVIS LABS FL. Form: CAPSULE. Route: ORAL
Sponsor: PADAGIS US. Form: SYSTEM. Route: TRANSDERMAL
Sponsor: PADAGIS US. Form: SYSTEM. Route: TRANSDERMAL
Sponsor: UPSHER SMITH LABS. Form: CAPSULE. Route: ORAL
Sponsor: IMPAX LABS. Form: TABLET. Route: ORAL
Sponsor: DR REDDYS LABS LTD. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: CAPSULE. Route: ORAL
Sponsor: AMNEAL PHARMS NY. Form: CAPSULE. Route: ORAL
Sponsor: UPSHER SMITH LABS. Form: CAPSULE. Route: ORAL
Sponsor: DR REDDYS LABS LTD. Form: TABLET. Route: ORAL