CisplatinGeneric products containing cisplatin Aortic thrombosis FDA has determined that the last approved labeling is adequate, and that no further regulatory action is needed at this […]

For Immediate Release: March 04, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, […]

Overview This page provides an overview of human drugs and the requirements that FDA verifies and enforces at the time they are imported or offered for […]

Product: Drugs Recipient: Recipient Name Dr. Krishna Prasad Chigurupati Recipient Title Chairman and Managing Director Granules India Limited Survey No 160/A, 161/E, 162 and 174/A, Gagillapur […]

Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER February 25, 2025 RE: 702106 Dear Sir/Madam: This letter concerns your […]

Product: Drugs Recipient: Recipient Name Kelly Chan TKTX Store 391 Sutter StreetSan Francisco, CA 94108United States [email protected] Issuing Office: Center for Drug Evaluation and Research (CDER) […]

Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER February 25, 2025 RE: 697051 Dear Sir/Madam: This letter concerns your […]

Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER February 25, 2025 RE: 698435 Dear Sir/Madam: This letter concerns your […]

Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-25-44 Product: Drugs Recipient: Recipient Name Mr. Jason Archer Recipient Title General Manager Chem-Tech, Ltd. 1006 Business […]