CDER New: 9/17/2020

What's New Related to Drugs

Updated Monday through Friday:

• Drug Firm Annual Registration Status
• Drug Firm Annual Registration Status Download File
• National Drug Code Directory
• NDC Unfinished Drugs Excluded Database File
• NDC Database Excluded Packages and Products
• Wholesale Distributor and Third-Party Logistics Providers Reporting

September 16, 2020

• Drugs@FDA Data Files (updated)
• FDA updates on hand sanitizers consumers should not use (updated)

Recent New and Generic Drug Approvals

This report displays final approvals and tentative approvals of original and supplemental applications for the two days beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this time span. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.

September 15, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Adcirca NDA #022332	Tadalafil	Tablet; Oral	SUPPL-11	Eli Lilly Co	Labeling	Approved
Brilinta NDA #022433	Ticagrelor	Tablet; Oral	SUPPL-30	Astrazeneca Pharms	Labeling	Approved
Dexmedetomidine Hydrochloride ANDA #208266	Dexmedetomidine Hydrochloride	Injectable; Injection	ORIG-1	Par Sterile Products		Approved
Dextrose 5% and Sodium Chloride 0.225% ANDA #211221	Dextrose; Sodium Chloride	Injectable; Injection	ORIG-1	Fresenius Kabi Usa		Approved
Dextrose 5% and Sodium Chloride 0.45% ANDA #211276	Dextrose; Sodium Chloride	Injectable; Injection	ORIG-1	Fresenius Kabi Usa		Approved
Lisinopril ANDA #212041	Lisinopril	Tablet; Oral	ORIG-1	Yiling		Approved
Chlorzoxazone ANDA #212053	Chlorzoxazone	Tablet; Oral	ORIG-1	I3 Pharms		Approved
Tofacitinib ANDA #212943	Tofacitinib	Unknown	ORIG-1	Ajanta Pharma Ltd		Tentative Approval

September 14, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Lenvima NDA #206947	Lenvatinib Mesylate	Capsule; Oral	SUPPL-17	Eisai Inc	Labeling	Approved
Apixaban ANDA #209898	Apixaban	Tablet; Oral	ORIG-1	Indoco		Approved
Dextrose 5% and Sodium Chloride 0.9% ANDA #211211	Dextrose; Sodium Chloride	Injectable; Injection	ORIG-1	Fresenius Kabi Usa		Approved