Details for New Drug Application (NDA): 208782
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The generic ingredient in ENTECAVIR is entecavir. There are eighteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the entecavir profile page.
Summary for 208782
Tradename: | ENTECAVIR |
Applicant: | Prinston Inc |
Ingredient: | entecavir |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208782
Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 208782
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ENTECAVIR | entecavir | TABLET;ORAL | 208782 | ANDA | Solco Healthcare LLC | 43547-436 | 43547-436-03 | 30 TABLET, FILM COATED in 1 BOTTLE (43547-436-03) |
ENTECAVIR | entecavir | TABLET;ORAL | 208782 | ANDA | Solco Healthcare LLC | 43547-436 | 43547-436-09 | 90 TABLET, FILM COATED in 1 BOTTLE (43547-436-09) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
Approval Date: | Oct 10, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Oct 10, 2017 | TE: | AB | RLD: | No |
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