← FDA Drug Approvals (Drugs@FDA)
CEVIMELINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: RUBICON RESEARCH · Approved 2023-04-06
Drug application
- FDA Application #
ANDA216682- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- CEVIMELINE HYDROCHLORIDE
- Generic name
- CEVIMELINE HYDROCHLORIDE
- Active ingredients
- CEVIMELINE HYDROCHLORIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- RUBICON RESEARCH
- Manufacturer
- Advagen Pharma Ltd
- First approval
- 2023-04-06
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown