← FDA Drug Approvals (Drugs@FDA)
ESOMEPRAZOLE MAGNESIUM
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GUARDIAN DRUG · Approved 2023-03-15
Drug application
- FDA Application #
ANDA216149
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- ESOMEPRAZOLE MAGNESIUM
- Generic name
- ESOMEPRAZOLE MAGNESIUM
- Active ingredients
- ESOMEPRAZOLE MAGNESIUM
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- GUARDIAN DRUG
- Manufacturer
- Guardian Drug Company
- First approval
- 2023-03-15
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown