Details for New Drug Application (NDA): 209721
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The generic ingredient in EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE is emtricitabine; tenofovir disoproxil fumarate. There are eighteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the emtricitabine; tenofovir disoproxil fumarate profile page.
Summary for 209721
Tradename: | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE |
Applicant: | Amneal Pharms Co |
Ingredient: | emtricitabine; tenofovir disoproxil fumarate |
Patents: | 0 |
Pharmacology for NDA: 209721
Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 209721
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 209721 | ANDA | AvKARE | 42291-439 | 42291-439-30 | 30 TABLET, FILM COATED in 1 BOTTLE (42291-439-30) |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 209721 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-2095 | 60219-2095-3 | 30 TABLET, FILM COATED in 1 BOTTLE (60219-2095-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG;150MG | ||||
Approval Date: | Aug 22, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 133MG;200MG | ||||
Approval Date: | Aug 22, 2018 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 167MG;250MG | ||||
Approval Date: | Aug 22, 2018 | TE: | AB | RLD: | No |
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