← FDA Drug Approvals (Drugs@FDA)
LORATADINE AND PSEUDOEPHEDRINE SULFATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: DR REDDYS · Approved 2026-08-06
Drug application
- FDA Application #
ANDA220448
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- LORATADINE AND PSEUDOEPHEDRINE SULFATE
- Generic name
- Loratadine
- Active ingredients
- LORATADINE; PSEUDOEPHEDRINE SULFATE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- DR REDDYS
- First approval
- 2026-08-06
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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