← FDA Drug Approvals (Drugs@FDA)
PROPAFENONE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA LTD · Approved 2023-02-21
Drug application
- FDA Application #
ANDA213096
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PROPAFENONE HYDROCHLORIDE
- Generic name
- PROPAFENONE HYDROCHLORIDE
- Active ingredients
- PROPAFENONE HYDROCHLORIDE
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- AUROBINDO PHARMA LTD
- Manufacturer
- Aurobindo Pharma Limited
- First approval
- 2023-02-21
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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