← FDA Drug Approvals (Drugs@FDA)
OTOBIOTIC
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SCHERING · Approved 1981-12-01
Drug application
- FDA Application #
ANDA062302- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- OTOBIOTIC
- Generic name
- Hydrocortisone
- Active ingredients
- HYDROCORTISONE; POLYMYXIN B SULFATE
- Dosage form
- SOLUTION/DROPS
- Route
- OTIC
- Marketing status
- Discontinued
- Sponsor
- SCHERING
- First approval
- 1981-12-01
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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