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LOPERAMIDE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MARKSANS PHARMA · Approved 2025-11-17
Drug application
- FDA Application #
ANDA220153- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- LOPERAMIDE HYDROCHLORIDE
- Generic name
- LOPERAMIDE HYDROCHLORIDE TABLETS USP, 2MG
- Active ingredients
- LOPERAMIDE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- MARKSANS PHARMA
- Manufacturer
- MARKSANS PHARMA LIMITED
- First approval
- 2025-11-17
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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