← FDA Drug Approvals (Drugs@FDA)
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL · Approved 2025-09-30
Drug application
- FDA Application #
ANDA217735- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
- Generic name
- NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE
- Active ingredients
- HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
- Dosage form
- SUSPENSION/DROPS
- Route
- OTIC
- Marketing status
- Prescription
- Sponsor
- AMNEAL
- Manufacturer
- Amneal Pharmaceuticals NY LLC
- First approval
- 2025-09-30
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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