← FDA Drug Approvals (Drugs@FDA)
PROMETHAZINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: QUAGEN · Approved 2021-07-12
Drug application
- FDA Application #
ANDA213890- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PROMETHAZINE HYDROCHLORIDE
- Generic name
- PROMETHAZINE HYDROCHLORIDE
- Active ingredients
- PROMETHAZINE HYDROCHLORIDE
- Dosage form
- SYRUP
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- QUAGEN
- Manufacturer
- QUAGEN PHARMACEUTICALS LLC
- First approval
- 2021-07-12
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown