← FDA Drug Approvals (Drugs@FDA)
PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA LTD · Approved 2025-12-29
Drug application
- FDA Application #
ANDA218854- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PSEUDOEPHEDRINE HYDROCHLORIDE
- Generic name
- PSEUDOEPHEDRINE HYDROCHLORIDE
- Active ingredients
- PSEUDOEPHEDRINE HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- AUROBINDO PHARMA LTD
- Manufacturer
- WALGREEN CO.
- First approval
- 2025-12-29
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown