Details for New Drug Application (NDA): 209498
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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 209498
Tradename: | TENOFOVIR DISOPROXIL FUMARATE |
Applicant: | Qilu |
Ingredient: | tenofovir disoproxil fumarate |
Patents: | 0 |
Pharmacology for NDA: 209498
Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 209498
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TENOFOVIR DISOPROXIL FUMARATE | tenofovir disoproxil fumarate | TABLET;ORAL | 209498 | ANDA | Quinn Pharmaceuticals | 69076-105 | 69076-105-03 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (69076-105-03) |
TENOFOVIR DISOPROXIL FUMARATE | tenofovir disoproxil fumarate | TABLET;ORAL | 209498 | ANDA | Bryant Ranch Prepack | 71335-2364 | 71335-2364-1 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (71335-2364-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Mar 2, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Mar 2, 2018 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
Approval Date: | Mar 2, 2018 | TE: | AB | RLD: | No |
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