← FDA Drug Approvals (Drugs@FDA)
ESOMEPRAZOLE MAGNESIUM
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HETERO LABS LTD III · Approved 2020-06-02
Drug application
- FDA Application #
ANDA212507
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- ESOMEPRAZOLE MAGNESIUM
- Generic name
- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE
- Active ingredients
- ESOMEPRAZOLE MAGNESIUM
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- HETERO LABS LTD III
- Manufacturer
- Allegiant Health
- First approval
- 2020-06-02
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown