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DILTIAZEM HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC · Approved 2025-11-14
Drug application
- FDA Application #
ANDA217633- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- DILTIAZEM HYDROCHLORIDE
- Generic name
- DILTIAZEM HYDROCHLORIDE
- Active ingredients
- DILTIAZEM HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ALEMBIC
- Manufacturer
- Alembic Pharmaceuticals Limited
- First approval
- 2025-11-14
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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