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FDA ANDA · ANDA076648

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

Sponsor: CHARTWELL RX

APPLICATION
ANDA076648
TYPE
ANDA
ORIGINAL APPROVAL
2004-03-22
LATEST ACTION
2016-02-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Discontinued
NITROFURANTOIN 75MG, NITROFURANTOIN, MACROCRYSTALLINE 25MG · CAPSULE · ORAL

Approval history

2016-02-16Labeling · Supplement 8 · standardAP
2012-11-20Labeling · Supplement 6 · standardAP
2008-07-24Labeling · Supplement 4AP
2004-03-22Original — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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