Details for New Drug Application (NDA): 216857
NDA 216857 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, Pharmadax, Prinston Inc, Rising, Sunshine, Teva Pharms Usa, Yaopharma Co Ltd, Yung Shin Pharm, and Zydus Pharms, and is included in eighteen NDAs. It is available from fifteen suppliers. Additional details are available on the ENTECAVIR profile page.
The generic ingredient in ENTECAVIR is entecavir. There is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the entecavir profile page.
The generic ingredient in ENTECAVIR is entecavir. There is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the entecavir profile page.
Pharmacology for NDA: 216857
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 216857
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ENTECAVIR | entecavir | TABLET;ORAL | 216857 | ANDA | Cameron Pharmaceuticals | 42494-457 | 42494-457-30 | 30 TABLET in 1 BOTTLE (42494-457-30) |
| ENTECAVIR | entecavir | TABLET;ORAL | 216857 | ANDA | Cameron Pharmaceuticals | 42494-458 | 42494-458-30 | 30 TABLET in 1 BOTTLE (42494-458-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Dec 23, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Dec 23, 2024 | TE: | AB | RLD: | No | ||||
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