# NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
> **ANDA217073** · Abbreviated New Drug Application (Generic) · Sponsor: OMSAV PHARMA · Approved 2023-11-03
## Drug
- **FDA Application Number:** 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
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217073)
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