APPLICATION
NDA013684
TYPE
NDA
ORIGINAL APPROVAL
1964-06-08
LATEST ACTION
2019-08-05
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
OSMITROL 20% IN WATER IN PLASTIC CONTAINER · ReferencePrescription
MANNITOL 20GM/100ML · INJECTABLE · INJECTION
OSMITROL 5% IN WATER IN PLASTIC CONTAINERPrescription
MANNITOL 5GM/100ML · INJECTABLE · INJECTION
OSMITROL 20% IN WATERPrescription
MANNITOL 20GM/100ML · INJECTABLE · INJECTION
OSMITROL 5% IN WATERPrescription
MANNITOL 5GM/100ML · INJECTABLE · INJECTION
OSMITROL 15% IN WATER IN PLASTIC CONTAINERPrescription
MANNITOL 15GM/100ML · INJECTABLE · INJECTION
OSMITROL 10% IN WATER IN PLASTIC CONTAINERPrescription
MANNITOL 10GM/100ML · INJECTABLE · INJECTION
OSMITROL 15% IN WATERPrescription
MANNITOL 15GM/100ML · INJECTABLE · INJECTION
OSMITROL 10% IN WATERPrescription
MANNITOL 10GM/100ML · INJECTABLE · INJECTION
Approval history
2015-12-23Manufacturing (CMC) · Supplement 101 · standardAP
2015-07-15Manufacturing (CMC) · Supplement 100 · standardAP
2015-04-08Manufacturing (CMC) · Supplement 99 · standardAP
2013-07-19Manufacturing (CMC) · Supplement 97 · standardAP
2002-01-16Manufacturing (CMC) · Supplement 87 · standardAP
2001-08-14Manufacturing (CMC) · Supplement 86 · standardAP
1999-11-24Manufacturing (CMC) · Supplement 85 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 84 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 82 · standardAP
1994-06-01Manufacturing (CMC) · Supplement 81 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 83 · standardAP
1991-04-29Manufacturing (CMC) · Supplement 79 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 78 · standardAP
1991-02-15Manufacturing (CMC) · Supplement 77 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 76 · standardAP
1987-07-25Manufacturing (CMC) · Supplement 75 · standardAP
1987-05-28Manufacturing (CMC) · Supplement 74 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 64 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 65 · standardAP
1985-06-13Manufacturing (CMC) · Supplement 70 · standardAP
1985-04-15Manufacturing (CMC) · Supplement 71 · standardAP
1985-01-24Manufacturing (CMC) · Supplement 62 · standardAP
1984-09-22Manufacturing (CMC) · Supplement 69 · standardAP
1984-03-16Manufacturing (CMC) · Supplement 63 · standardAP
1984-02-28Manufacturing (CMC) · Supplement 68 · standardAP
1983-07-11Labeling · Supplement 67AP
1982-11-22Manufacturing (CMC) · Supplement 50 · standardAP
1982-11-22Labeling · Supplement 55AP
1982-11-22Labeling · Supplement 51AP
1982-06-03Manufacturing (CMC) · Supplement 56 · standardAP
1982-04-16Manufacturing (CMC) · Supplement 54 · standardAP
1982-04-08Labeling · Supplement 60AP
1982-02-16Manufacturing (CMC) · Supplement 59 · standardAP
1981-11-20Manufacturing (CMC) · Supplement 58 · standardAP
1981-09-08Manufacturing (CMC) · Supplement 43 · standardAP
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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