← FDA Drug Approvals (Drugs@FDA)
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SANDOZ · Approved 2005-04-05
Drug application
- FDA Application #
ANDA077066- 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
- SANDOZ
- Manufacturer
- Sandoz Inc
- First approval
- 2005-04-05
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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