← FDA Drug Approvals (Drugs@FDA)
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA LTD · Approved 2019-02-14
Drug application
- FDA Application #
ANDA210676- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
- Generic name
- DIPHENHYDRAMINE HCL AND IBUPROFEN
- Active ingredients
- DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- AUROBINDO PHARMA LTD
- Manufacturer
- Aurohealth LLC
- First approval
- 2019-02-14
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown