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LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GRANULES · Approved 2022-08-29
Drug application
- FDA Application #
ANDA215981- 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
- Discontinued
- Sponsor
- GRANULES
- Manufacturer
- Granules India Ltd
- First approval
- 2022-08-29
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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