Details for New Drug Application (NDA): 021797
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The generic ingredient in BARACLUDE 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 021797
Tradename: | BARACLUDE |
Applicant: | Bristol Myers Squibb |
Ingredient: | entecavir |
Patents: | 0 |
Pharmacology for NDA: 021797
Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 021797
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BARACLUDE | entecavir | TABLET;ORAL | 021797 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-1611 | 0003-1611-12 | 1 BOTTLE in 1 CARTON (0003-1611-12) / 30 TABLET, FILM COATED in 1 BOTTLE |
BARACLUDE | entecavir | TABLET;ORAL | 021797 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-1612 | 0003-1612-12 | 1 BOTTLE in 1 CARTON (0003-1612-12) / 30 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
Approval Date: | Mar 29, 2005 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Mar 29, 2005 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021797
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bristol Myers Squibb | BARACLUDE | entecavir | TABLET;ORAL | 021797-001 | Mar 29, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | BARACLUDE | entecavir | TABLET;ORAL | 021797-002 | Mar 29, 2005 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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