| NDC Code | 0378-5440-93 |
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| Package Description | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5440-93) |
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| Product NDC | 0378-5440 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate |
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| Non-Proprietary Name | Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate |
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| Dosage Form | TABLET, FILM COATED |
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| Usage | ORAL |
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| Start Marketing Date | 20250527 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA208452 |
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| Manufacturer | Mylan Pharmaceuticals Inc. |
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| Substance Name | EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE |
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| Strength | 200; 25; 300 |
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| Strength Unit | mg/1; mg/1; mg/1 |
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| Pharmacy Classes | Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS] |
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