← FDA Drug Approvals (Drugs@FDA)
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HETERO LABS LTD V · Approved 2021-06-17
Drug application
- FDA Application #
ANDA211438- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
- Generic name
- LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
- Active ingredients
- LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- HETERO LABS LTD V
- Manufacturer
- Camber Consumer Care Inc
- First approval
- 2021-06-17
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown