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FDA NDA · NDA020006

MANNITOL

Sponsor: B BRAUN

APPLICATION
NDA020006
TYPE
NDA
ORIGINAL APPROVAL
1993-07-26
LATEST ACTION
2019-09-24
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

MANNITOL 20% IN PLASTIC CONTAINERPrescription
MANNITOL 20GM/100ML · INJECTABLE · INJECTION
MANNITOL 10% IN PLASTIC CONTAINERPrescription
MANNITOL 10GM/100ML · INJECTABLE · INJECTION
MANNITOL 15% IN PLASTIC CONTAINERPrescription
MANNITOL 15GM/100ML · INJECTABLE · INJECTION
MANNITOL 5% IN PLASTIC CONTAINERPrescription
MANNITOL 5GM/100ML · INJECTABLE · INJECTION

Approval history

2019-09-24Efficacy · Supplement 28 · standard — Label ↗AP
2019-01-09Labeling · Supplement 25 · standard — Label ↗AP
2005-04-20Labeling · Supplement 9AP
2002-07-01Manufacturing (CMC) · Supplement 5 · standardAP
2002-04-15Manufacturing (CMC) · Supplement 3 · standardAP
2000-12-07Manufacturing (CMC) · Supplement 2 · standardAP
1998-08-21Manufacturing (CMC) · Supplement 1 · standardAP
1993-07-26Type 5 - New Formulation or New Manufacturer · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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