← FDA Drug Approvals (Drugs@FDA)
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: INVENTIA · Approved 2022-02-18
Drug application
- FDA Application #
ANDA211013- 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
- INVENTIA
- Manufacturer
- Jubilant Cadista Pharmaceuticals Inc.
- First approval
- 2022-02-18
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown