← FDA Drug Approvals (Drugs@FDA)
RABEPRAZOLE SODIUM
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2018-04-24
Drug application
- FDA Application #
ANDA208644- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- RABEPRAZOLE SODIUM
- Generic name
- RABEPRAZOLE SODIUM
- Active ingredients
- RABEPRAZOLE SODIUM
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ALKEM LABS LTD
- Manufacturer
- Ascend Laboratories, LLC
- First approval
- 2018-04-24
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown