← FDA Drug Approvals (Drugs@FDA)
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CHARTWELL RX · Approved 2004-03-22
Drug application
- FDA Application #
ANDA076648- 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
- Discontinued
- Sponsor
- CHARTWELL RX
- First approval
- 2004-03-22
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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