← FDA Drug Approvals (Drugs@FDA)
APLENZIN
NDA · New Drug Application · Sponsor: BAUSCH · Approved 2008-04-23
Drug application
- FDA Application #
NDA022108
- Application type
- New Drug Application
- Brand name
- APLENZIN
- Generic name
- BUPROPION HYDROBROMIDE
- Active ingredients
- BUPROPION HYDROBROMIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- BAUSCH
- Manufacturer
- Bausch Health US, LLC
- First approval
- 2008-04-23
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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