← FDA Drug Approvals (Drugs@FDA)
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: OMSAV PHARMA · Approved 2023-11-03
Drug application
- FDA Application #
ANDA217073- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
- Generic name
- NITROFURANTOIN
- Active ingredients
- NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- OMSAV PHARMA
- Manufacturer
- Micro Labs Limited
- First approval
- 2023-11-03
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown