← FDA Drug Approvals (Drugs@FDA)
LOPERAMIDE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: EDENBRIDGE PHARMS · Approved 2021-10-06
Drug application
- FDA Application #
ANDA215001
- 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
- Prescription
- Sponsor
- EDENBRIDGE PHARMS
- Manufacturer
- Edenbridge Pharmaceuticals LLC.
- First approval
- 2021-10-06
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown