Details for New Drug Application (NDA): 090636
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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 090636
Tradename: | TENOFOVIR DISOPROXIL FUMARATE |
Applicant: | Hetero Labs Ltd Iii |
Ingredient: | tenofovir disoproxil fumarate |
Patents: | 0 |
Pharmacology for NDA: 090636
Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 090636
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TENOFOVIR DISOPROXIL FUMARATE | tenofovir disoproxil fumarate | TABLET;ORAL | 090636 | ANDA | NorthStar RxLLC | 16714-820 | 16714-820-01 | 30 TABLET, FILM COATED in 1 BOTTLE (16714-820-01) |
TENOFOVIR DISOPROXIL FUMARATE | tenofovir disoproxil fumarate | TABLET;ORAL | 090636 | ANDA | Camber Pharmaceuticals, Inc. | 31722-535 | 31722-535-01 | 100 TABLET, FILM COATED in 1 BOTTLE (31722-535-01) |
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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