Details for New Drug Application (NDA): 090742
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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. Fifteen suppliers are listed for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.
Summary for 090742
Tradename: | TENOFOVIR DISOPROXIL FUMARATE |
Applicant: | Strides Pharma |
Ingredient: | tenofovir disoproxil fumarate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090742
Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 090742
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TENOFOVIR DISOPROXIL FUMARATE | tenofovir disoproxil fumarate | TABLET;ORAL | 090742 | ANDA | AvPAK | 50268-758 | 50268-758-12 | 20 BLISTER PACK in 1 BOX (50268-758-12) / 1 TABLET in 1 BLISTER PACK (50268-758-11) |
TENOFOVIR DISOPROXIL FUMARATE | tenofovir disoproxil fumarate | TABLET;ORAL | 090742 | ANDA | Strides Pharma Science Limited | 64380-714 | 64380-714-04 | 30 TABLET in 1 BOTTLE (64380-714-04) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
Approval Date: | Jan 26, 2018 | TE: | AB | RLD: | No |
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