← FDA Drug Approvals (Drugs@FDA)
DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HETERO LABS LTD III · Approved 2024-08-28
Drug application
- FDA Application #
ANDA218426- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE
- Generic name
- DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE
- Active ingredients
- DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- HETERO LABS LTD III
- Manufacturer
- Camber Pharmaceuticals, Inc.
- First approval
- 2024-08-28
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown