Details for New Drug Application (NDA): 206652
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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 206652
Tradename: | ENTECAVIR |
Applicant: | Amneal Pharms |
Ingredient: | entecavir |
Patents: | 0 |
Pharmacology for NDA: 206652
Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 206652
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ENTECAVIR | entecavir | TABLET;ORAL | 206652 | ANDA | AvKARE | 42291-261 | 42291-261-30 | 30 TABLET, FILM COATED in 1 BOTTLE (42291-261-30) |
ENTECAVIR | entecavir | TABLET;ORAL | 206652 | ANDA | AvKARE | 42291-262 | 42291-262-30 | 30 TABLET, FILM COATED in 1 BOTTLE (42291-262-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
Approval Date: | Nov 12, 2015 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Nov 12, 2015 | TE: | AB | RLD: | No |
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