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DILTIAZEM HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMTA · Approved 2023-03-07
Drug application
- FDA Application #
ANDA216439- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- DILTIAZEM HYDROCHLORIDE
- Generic name
- DILTIAZEM HYDROCHLORIDE
- Active ingredients
- DILTIAZEM HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- AMTA
- Manufacturer
- Slate Run Pharmaceuticals, LLC
- First approval
- 2023-03-07
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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