# NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
> **ANDA217357** · Abbreviated New Drug Application (Generic) · Sponsor: MANKIND PHARMA · Approved 2023-07-11
## Drug
- **FDA Application Number:** ANDA217357
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
- **Generic name:** NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
- **Active ingredients:** NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** MANKIND PHARMA
- **Manufacturer:** NorthStar RxLLC
- **First approval:** 2023-07-11
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217357)
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