← FDA Drug Approvals (Drugs@FDA)
ESOMEPRAZOLE MAGNESIUM
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GRANULES · Approved 2023-10-18
Drug application
- FDA Application #
ANDA217427- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- ESOMEPRAZOLE MAGNESIUM
- Generic name
- ESOMEPRAZOLE MAGNESIUM
- Active ingredients
- ESOMEPRAZOLE MAGNESIUM
- Dosage form
- CAPSULE, DELAYED REL PELLETS
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- GRANULES
- Manufacturer
- Granules Pharmaceuticals Inc.
- First approval
- 2023-10-18
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown