← FDA Drug Approvals (Drugs@FDA)
ISOSORBIDE MONONITRATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SHANDONG · Approved 2022-04-29
Drug application
- FDA Application #
ANDA214115- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- ISOSORBIDE MONONITRATE
- Generic name
- ISOSORBIDE MONONITRATE
- Active ingredients
- ISOSORBIDE MONONITRATE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- SHANDONG
- Manufacturer
- Shandong New Time Pharmaceutical Co., Ltd.
- First approval
- 2022-04-29
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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