Details for New Drug Application (NDA): 079188
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The generic ingredient in EMTRICITABINE is emtricitabine; tenofovir alafenamide fumarate. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the emtricitabine; tenofovir alafenamide fumarate profile page.
Summary for 079188
Tradename: | EMTRICITABINE |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | emtricitabine |
Patents: | 0 |
Pharmacology for NDA: 079188
Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Medical Subject Heading (MeSH) Categories for 079188
Suppliers and Packaging for NDA: 079188
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EMTRICITABINE | emtricitabine | CAPSULE;ORAL | 079188 | ANDA | Aurobindo Pharma Limited | 65862-301 | 65862-301-05 | 500 CAPSULE in 1 BOTTLE (65862-301-05) |
EMTRICITABINE | emtricitabine | CAPSULE;ORAL | 079188 | ANDA | Aurobindo Pharma Limited | 65862-301 | 65862-301-30 | 30 CAPSULE in 1 BOTTLE (65862-301-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
Approval Date: | Mar 15, 2023 | TE: | AB | RLD: | No |
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