| NDC Code | 53002-1653-6 |
|---|
| Package Description | 6 TABLET, FILM COATED in 1 BOTTLE (53002-1653-6) |
|---|
| 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] |
|---|