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NITROFURANTOIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA USA · Approved 1997-07-09

Drug application

FDA Application #
ANDA074967
Application type
Abbreviated New Drug Application (Generic)
Brand name
NITROFURANTOIN
Generic name
NITROFURANTOIN (MACROCRYSTALS)
Active ingredients
NITROFURANTOIN, MACROCRYSTALLINE
Dosage form
CAPSULE
Route
ORAL
Marketing status
Prescription
Sponsor
AUROBINDO PHARMA USA
Manufacturer
Aurobindo Pharma Limited
First approval
1997-07-09

Source

Authoritative
Drugs@FDA application overview
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