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CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: UNICHEM · Approved 2024-09-10
Drug application
- FDA Application #
ANDA210507- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Generic name
- Cetirizine Hydrochloride
- Active ingredients
- CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- UNICHEM
- First approval
- 2024-09-10
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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