calendar
20,113 catalysts · 18,987 approval · 7,208 phase readout · 5,000 device 510k · 4,728 grant · 3,603 8k filing · 2,000 device pma
20,113 catalysts · 18,987 approval · 7,208 phase readout · 5,000 device 510k · 4,728 grant · 3,603 8k filing · 2,000 device pma
no tagged catalysts yet
Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: ABBVIE. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: AMNEAL. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: YILING. Form: CAPSULE. Route: ORAL
Sponsor: YILING. Form: CAPSULE. Route: ORAL
Sponsor: UCB INC. Form: SOLUTION. Route: ORAL
Sponsor: HETERO LABS LTD V. Form: TABLET. Route: ORAL
Sponsor: HETERO LABS LTD V. Form: TABLET. Route: ORAL
Sponsor: HETERO LABS LTD V. Form: TABLET. Route: ORAL
Sponsor: HETERO LABS LTD V. Form: TABLET. Route: ORAL
Sponsor: HETERO LABS LTD V. Form: TABLET. Route: ORAL
Sponsor: NOVAST LABS. Form: TABLET. Route: ORAL
Sponsor: NOVAST LABS. Form: TABLET. Route: ORAL
Sponsor: MERCK SHARP AND DOHME LLC
Sponsor: TAIHO ONCOLOGY. Form: TABLET. Route: ORAL
Sponsor: ASPIRO. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: ASPIRO. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: TORRENT. Form: TABLET. Route: ORAL
Sponsor: TORRENT. Form: TABLET. Route: ORAL
Sponsor: NANJING KING FRIEND. Form: SOLUTION. Route: SUBCUTANEOUS
Reconstitution XO Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health a) 5% Exosomes, 10 mL vial and b) 10% Exosomes, 5 mL vial, Extension Health a) 20% Exosomes, 10 mL vial, b) 10% Exosomes, 10 mL vial and Medical Health Institute (MHI), a) 10 % Exosomes, 2mL vial, 5mL vial, 10mL vial, b) 5% Exosomes, 2mL vial, 5mL vial, 10mL vial. — Reason: Lack of Assurance of Sterility — Status: Ongoing
Glycine for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 — Reason: Lack of Assurance of Sterility — Status: Ongoing
GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing
Magnesium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing
Cerebrolysin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing
L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 — Reason: Lack of Assurance of Sterility — Status: Ongoing
N-Acetyl-L-Cysteine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing
NAD+ (Nicotinamide adenine dinucleotide), a) 50 mg/mL, b) 100 mg/mL, 10 mL multi-dose vials, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health — Reason: Lack of Assurance of Sterility — Status: Ongoing
Methylene Blue for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing
Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x28 tablets blister cards per carton, Rx only, Manufactured for AvKARE, Pulaski, TN 38478. Carton NDC: 42291-565-84; Blister NDC: 42291-565-28 — Reason: Failed Content Uniformity Specifications — Status: Ongoing
Lysine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing
Biotin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing
Calcium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing
Amino Blend for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing
Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health and Synergy Wellness 60mg, 10mL vial lyophilized. — Reason: Lack of Assurance of Sterility — Status: Ongoing
Bacteriostatic Water for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health, Extension Health and Medical Health Institute — Reason: Lack of Assurance of Sterility — Status: Ongoing
Taurine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing
L-Arginine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Tri-Immune for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing
Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7133-61, UPC (01)00309047133611 NDC 0904-7133-61 — Reason: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit — Status: Ongoing
Vitamin D3 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing
BPC-157 for Injection, 15mg/10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Medical Health Institute (MHI), 15mg, 10mL vial lyophilized. — Reason: Lack of Assurance of Sterility — Status: Ongoing
Retatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 — Reason: Lack of Assurance of Sterility — Status: Ongoing