← FDA Drug Approvals (Drugs@FDA)
PROCAINAMIDE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CAPLIN · Approved 2025-02-04
Drug application
- FDA Application #
ANDA218674- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PROCAINAMIDE HYDROCHLORIDE
- Generic name
- PROCAINAMIDE HYDROCHLORIDE
- Active ingredients
- PROCAINAMIDE HYDROCHLORIDE
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Prescription
- Sponsor
- CAPLIN
- Manufacturer
- Caplin Steriles Limited
- First approval
- 2025-02-04
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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