← FDA Drug Approvals (Drugs@FDA)
LORATADINE AND PSEUDOEPHEDRINE SULFATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: BIONPHARMA · Approved 2024-05-14
Drug application
- FDA Application #
ANDA218017- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- LORATADINE AND PSEUDOEPHEDRINE SULFATE
- Generic name
- LORATADINE AND PSEUDOEPHEDRINE SULFATE
- Active ingredients
- LORATADINE; PSEUDOEPHEDRINE SULFATE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- BIONPHARMA
- Manufacturer
- HEB
- First approval
- 2024-05-14
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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