← FDA Drug Approvals (Drugs@FDA)
BARACLUDE
NDA · New Drug Application · Sponsor: BRISTOL MYERS SQUIBB · Approved 2005-03-29
Drug application
- FDA Application #
NDA021798
- Application type
- New Drug Application
- Brand name
- BARACLUDE
- Generic name
- ENTECAVIR
- Active ingredients
- ENTECAVIR
- Dosage form
- SOLUTION
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- BRISTOL MYERS SQUIBB
- Manufacturer
- E.R. Squibb & Sons, L.L.C.
- First approval
- 2005-03-29
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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