# NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
> **ANDA208516** · Abbreviated New Drug Application (Generic) · Sponsor: SUNNY · Approved 2018-05-24
## Drug
- **FDA Application Number:** ANDA208516
- **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:** SUNNY
- **Manufacturer:** Trigen Laboratories, LLC
- **First approval:** 2018-05-24
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208516)
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