← FDA Drug Approvals (Drugs@FDA)
COLESEVELAM HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: IMPAX LABS INC · Approved 2018-05-16
Drug application
- FDA Application #
ANDA091600
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- COLESEVELAM HYDROCHLORIDE
- Generic name
- COLESEVELAM HYDROCHLORIDE
- Active ingredients
- COLESEVELAM HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- IMPAX LABS INC
- Manufacturer
- Amneal Pharmaceuticals of New York LLC
- First approval
- 2018-05-16
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown