NDC Code | 53002-1653-5 |
Package Description | 5 TABLET, FILM COATED in 1 BOTTLE (53002-1653-5) |
Product NDC | 53002-1653 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Emtricitabine And Tenofovir Disoproxil Fumarate |
Non-Proprietary Name | Emtricitabine And Tenofovir Disoproxil Fumarate |
Dosage Form | TABLET, FILM COATED |
Usage | ORAL |
Start Marketing Date | 20210330 |
Marketing Category Name | ANDA |
Application Number | ANDA090513 |
Manufacturer | RPK Pharmaceuticals, Inc. |
Substance Name | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
Strength | 200; 300 |
Strength Unit | mg/1; mg/1 |
Pharmacy Classes | Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS] |