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LOPERAMIDE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA · Approved 2015-12-15
Drug application
- FDA Application #
ANDA206548
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- LOPERAMIDE HYDROCHLORIDE
- Generic name
- LOPERAMIDE HYDROCHLORIDE
- Active ingredients
- LOPERAMIDE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- AUROBINDO PHARMA
- Manufacturer
- Aurohealth LLC
- First approval
- 2015-12-15
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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