← FDA Drug Approvals (Drugs@FDA)
LOPERAMIDE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA · Approved 2025-12-29
Drug application
- FDA Application #
ANDA220372- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- LOPERAMIDE HYDROCHLORIDE
- Generic name
- LOPERAMIDE HYDROCHLORIDE
- Active ingredients
- LOPERAMIDE HYDROCHLORIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- AUROBINDO PHARMA
- Manufacturer
- Aurohealth LLC
- First approval
- 2025-12-29
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown