Details for New Drug Application (NDA): 021797
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NDA 021797 describes BARACLUDE, which is a drug marketed by Bristol Myers Squibb and is included in two NDAs. It is available from one supplier. Additional details are available on the BARACLUDE profile page.
The generic ingredient in BARACLUDE 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 BARACLUDE 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.
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 | ||||
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