Details for New Drug Application (NDA): 212201
✉ Email this page to a colleague
The generic ingredient in ENTECAVIR is entecavir. There are eighteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the entecavir profile page.
Summary for 212201
Tradename: | ENTECAVIR |
Applicant: | Yaopharma Co Ltd |
Ingredient: | entecavir |
Patents: | 0 |
Pharmacology for NDA: 212201
Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 212201
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ENTECAVIR | entecavir | TABLET;ORAL | 212201 | ANDA | Yaopharma Co., Ltd. | 50771-013 | 50771-013-01 | 30 TABLET, FILM COATED in 1 BOTTLE (50771-013-01) |
ENTECAVIR | entecavir | TABLET;ORAL | 212201 | ANDA | Yaopharma Co., Ltd. | 50771-013 | 50771-013-02 | 90 TABLET, FILM COATED in 1 BOTTLE (50771-013-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
Approval Date: | Nov 4, 2019 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Nov 4, 2019 | TE: | RLD: | No |
Complete Access Available with Subscription