← FDA Drug Approvals (Drugs@FDA)
LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HETERO LABS LTD III · Approved 2020-04-29
Drug application
- FDA Application #
ANDA213513
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- LEVOCETIRIZINE DIHYDROCHLORIDE
- Generic name
- LEVOCETIRIZINE DIHYDROCHLORIDE 5 MG
- Active ingredients
- LEVOCETIRIZINE DIHYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- HETERO LABS LTD III
- Manufacturer
- Little Pharma, Inc.
- First approval
- 2020-04-29
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown