← FDA Drug Approvals (Drugs@FDA)
FOSFOMYCIN TROMETHAMINE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL · Approved 2024-03-25
Drug application
- FDA Application #
ANDA216600
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- FOSFOMYCIN TROMETHAMINE
- Generic name
- FOSFOMYCIN TROMETHAMINE
- Active ingredients
- FOSFOMYCIN TROMETHAMINE
- Dosage form
- FOR SOLUTION
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- AMNEAL
- Manufacturer
- Amneal Pharmaceuticals NY LLC
- First approval
- 2024-03-25
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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