← FDA Drug Approvals (Drugs@FDA)
CETIRIZINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA LTD · Approved 2020-09-11
Drug application
- FDA Application #
ANDA213557- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- CETIRIZINE HYDROCHLORIDE
- Generic name
- CETIRIZINE HYDROCHLORIDE
- Active ingredients
- CETIRIZINE HYDROCHLORIDE
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- AUROBINDO PHARMA LTD
- Manufacturer
- Aurohealth LLC
- First approval
- 2020-09-11
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown