Details for New Drug Application (NDA): 090647
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The generic ingredient in TENOFOVIR DISOPROXIL FUMARATE is tenofovir disoproxil fumarate. There are forty-two drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.
Summary for 090647
Tradename: | TENOFOVIR DISOPROXIL FUMARATE |
Applicant: | Aurobindo Pharma |
Ingredient: | tenofovir disoproxil fumarate |
Patents: | 0 |
Pharmacology for NDA: 090647
Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 090647
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TENOFOVIR DISOPROXIL FUMARATE | tenofovir disoproxil fumarate | TABLET;ORAL | 090647 | ANDA | Aurobindo Pharma Limited | 65862-421 | 65862-421-30 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-421-30) |
TENOFOVIR DISOPROXIL FUMARATE | tenofovir disoproxil fumarate | TABLET;ORAL | 090647 | ANDA | Aurobindo Pharma Limited | 65862-818 | 65862-818-03 | 3 BLISTER PACK in 1 CARTON (65862-818-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Jan 26, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Jan 26, 2018 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Jan 26, 2018 | TE: | AB | RLD: | No |
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