← FDA Drug Approvals (Drugs@FDA)
BALSALAZIDE DISODIUM
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA · Approved 2007-12-28
Drug application
- FDA Application #
ANDA077806- 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
- HIKMA
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- First approval
- 2007-12-28
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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