← FDA Drug Approvals (Drugs@FDA)
KARBINAL ER
NDA · New Drug Application · Sponsor: AYTU · Approved 2013-03-28
Drug application
- FDA Application #
NDA022556- Application type
- New Drug Application
- Brand name
- KARBINAL ER
- Generic name
- CARBINOXAMINE MALEATE
- Active ingredients
- CARBINOXAMINE MALEATE
- Dosage form
- SUSPENSION, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- AYTU
- Manufacturer
- Neos Therapeutics, LP
- First approval
- 2013-03-28
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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