← FDA Drug Approvals (Drugs@FDA)
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA LTD · Approved 2023-03-10
Drug application
- FDA Application #
ANDA213565- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Generic name
- IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Active ingredients
- IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- AUROBINDO PHARMA LTD
- Manufacturer
- Aurohealth LLC
- First approval
- 2023-03-10
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown