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LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: BIONPHARMA · Approved 2021-09-10
Drug application
- FDA Application #
ANDA213484- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
- Generic name
- LOPERAMIDE HYDROCHLORIDE 2MG, SIMETHICONE 125MG
- Active ingredients
- LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- BIONPHARMA
- Manufacturer
- YYBA CORP
- First approval
- 2021-09-10
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown