Details for New Drug Application (NDA): 206872
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NDA 206872 describes ENTECAVIR, which is a drug marketed by Accord Hlthcare, Amneal Pharms, Aurobindo Pharma, Breckenridge, Brightgene, Chartwell Rx, Cipla, Conba Usa, Hetero Labs Ltd V, Prinston Inc, Rising, Sunshine, Swiss Pharm, Teva Pharms Usa, Yaopharma Co Ltd, Yung Shin Pharm, and Zydus Pharms, and is included in eighteen NDAs. It is available from fourteen suppliers. Additional details are available on the ENTECAVIR profile page.
The generic ingredient in ENTECAVIR is entecavir. There are eighteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the entecavir profile page.
The generic ingredient in ENTECAVIR is entecavir. There are eighteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the entecavir profile page.
Pharmacology for NDA: 206872
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 206872
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ENTECAVIR | entecavir | TABLET;ORAL | 206872 | ANDA | NorthStar RxLLC | 16714-717 | 16714-717-01 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16714-717-01) |
| ENTECAVIR | entecavir | TABLET;ORAL | 206872 | ANDA | NorthStar RxLLC | 16714-718 | 16714-718-01 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16714-718-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Dec 6, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Dec 6, 2016 | TE: | AB | RLD: | No | ||||
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