Details for New Drug Application (NDA): 091168
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NDA 091168 describes EMTRICITABINE, which is a drug marketed by Aurobindo Pharma Ltd, Cipla, Hetero Labs Ltd Iii, Apotex, Amneal Pharms Co, Aurobindo Pharma, Chartwell Rx, Laurus, Macleods Pharms Ltd, Mylan, Strides Pharma, Teva Pharms Usa, and Zydus Pharms, and is included in sixteen NDAs. It is available from two suppliers. Additional details are available on the EMTRICITABINE profile page.
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.
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 091168
| Tradename: | EMTRICITABINE |
| Applicant: | Cipla |
| Ingredient: | emtricitabine |
| Patents: | 0 |
Pharmacology for NDA: 091168
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Medical Subject Heading (MeSH) Categories for 091168
Suppliers and Packaging for NDA: 091168
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EMTRICITABINE | emtricitabine | CAPSULE;ORAL | 091168 | ANDA | Cipla USA Inc. | 69097-642 | 69097-642-02 | 30 CAPSULE in 1 BOTTLE (69097-642-02) |
| EMTRICITABINE | emtricitabine | CAPSULE;ORAL | 091168 | ANDA | Cipla USA Inc. | 69097-642 | 69097-642-15 | 1000 CAPSULE in 1 BOTTLE (69097-642-15) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
| Approval Date: | Jul 2, 2018 | TE: | AB | RLD: | No | ||||
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