← FDA Drug Approvals (Drugs@FDA)
DULOXETINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: IMPAX LABS INC · Approved 2010-11-18
Drug application
- FDA Application #
ANDA090669- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- DULOXETINE HYDROCHLORIDE
- Generic name
- Duloxetine Hydrochloride
- Active ingredients
- DULOXETINE HYDROCHLORIDE
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Marketing status
- None (Tentative Approval)
- Sponsor
- IMPAX LABS INC
- First approval
- 2010-11-18
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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