HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

2023 NDA Drug Name Purpose Approval Date  NDA 17031/S-041 Opill (norgestrel) tablet, 0.075 mg Prevention of pregnancy AP 7-13-23 NDA 208411/S-006 Narcan (naloxone hydrochloride, 4 mg) […]

On This Page Date: September 4, 2024 Time: 11:00 AM – 3:00 PM ET Agenda Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT […]

Applying for Membership on FDA Advisory Committees As part of the Food and Drug Administration’s (FDA’s) ongoing efforts to recruit qualified experts with minimal conflicts of […]

Delivery Method: UPS Next Day Signature Required Product: Drugs Recipient: Recipient Name Mr. Moisei Reyzis Recipient Title President Art of Beauty Company, Inc. 200 Egbert RoadBedford, […]

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Ms. Magdalena Blanco Recipient Title President Max Chemical Inc. Calle La Brisa #7 Urb. Industrial Sabana […]

Delivery Method: VIA Electronic Mail Return Confirmation Requested Product: Drugs Recipient: Recipient Name Darin Hoogendoorn Recipient Title President ARG Laboratories, Inc. 2639 Manana DriveDallas, TX 75220-1301United […]

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Hongbin Dai Recipient Title Chief Executive Officer of Hengrui Pharma Jiangsu Hengrui Pharmaceuticals Co., Ltd. 1288 […]

Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER July 9, 2024 RE: 684036 Dear Kyle […]