Details for New Drug Application (NDA): 021896
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NDA 021896 describes EMTRIVA, which is a drug marketed by Gilead and is included in two NDAs. It is available from one supplier. Additional details are available on the EMTRIVA profile page.
The generic ingredient in EMTRIVA is emtricitabine. There are eighteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the emtricitabine profile page.
The generic ingredient in EMTRIVA is emtricitabine. There are eighteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the emtricitabine profile page.
Summary for 021896
| Tradename: | EMTRIVA |
| Applicant: | Gilead |
| Ingredient: | emtricitabine |
| Patents: | 0 |
Pharmacology for NDA: 021896
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Medical Subject Heading (MeSH) Categories for 021896
Suppliers and Packaging for NDA: 021896
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EMTRIVA | emtricitabine | SOLUTION;ORAL | 021896 | NDA | Gilead Sciences, Inc. | 61958-0602 | 61958-0602-1 | 1 BOTTLE, DISPENSING in 1 CARTON (61958-0602-1) / 170 mL in 1 BOTTLE, DISPENSING |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 10MG/ML | ||||
| Approval Date: | Sep 28, 2005 | TE: | RLD: | Yes | |||||
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