← FDA Drug Approvals (Drugs@FDA)
BALSALAZIDE DISODIUM
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS LIFESCIENCES · Approved 2023-06-08
Drug application
- FDA Application #
ANDA217592
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- BALSALAZIDE DISODIUM
- Generic name
- BALSALAZIDE DISODIUM
- Active ingredients
- BALSALAZIDE DISODIUM
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ZYDUS LIFESCIENCES
- Manufacturer
- Zydus Lifesciences Limited
- First approval
- 2023-06-08
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown