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DILTIAZEM HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVAST LABS · Approved 2025-07-02
Drug application
- FDA Application #
ANDA218032- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- DILTIAZEM HYDROCHLORIDE
- Generic name
- DILTIAZEM HYDROCHLORIDE
- Active ingredients
- DILTIAZEM HYDROCHLORIDE
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- NOVAST LABS
- Manufacturer
- Ingenus Pharmaceuticals, LLC
- First approval
- 2025-07-02
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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