# MACROBID
> **NDA020064** · New Drug Application · Sponsor: ALMATICA · Approved 1991-12-24
## Drug
- **FDA Application Number:** NDA020064
- **Application type:** New Drug Application
- **Brand name:** MACROBID
- **Generic name:** NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE
- **Active ingredients:** NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ALMATICA
- **Manufacturer:** Alvogen Inc.
- **First approval:** 1991-12-24
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020064)
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