APPLICATION
NDA017636
TYPE
NDA
ORIGINAL APPROVAL
1976-06-21
LATEST ACTION
2002-04-12
ROUTE
IRRIGATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
SORBITOL-MANNITOL IN PLASTIC CONTAINERDiscontinued
MANNITOL 540MG/100ML, SORBITOL 2.7GM/100ML · SOLUTION · IRRIGATION
Approval history
2002-04-12Manufacturing (CMC) · Supplement 48 · standardAP
2000-02-09Labeling · Supplement 47 · standardAP
1998-02-04Manufacturing (CMC) · Supplement 46 · standardAP
1997-11-19Labeling · Supplement 45 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 44 · standardAP
1993-08-24Manufacturing (CMC) · Supplement 41 · standardAP
1992-06-30Manufacturing (CMC) · Supplement 42 · standardAP
1988-11-25Manufacturing (CMC) · Supplement 40 · standardAP
1986-08-29Manufacturing (CMC) · Supplement 39 · standardAP
1986-01-18Manufacturing (CMC) · Supplement 35 · standardAP
1985-10-29Manufacturing (CMC) · Supplement 38 · standardAP
1985-06-17Manufacturing (CMC) · Supplement 36 · standardAP
1984-10-22Manufacturing (CMC) · Supplement 34 · standardAP
1984-09-21Manufacturing (CMC) · Supplement 31 · standardAP
1984-08-25Manufacturing (CMC) · Supplement 32 · standardAP
1984-03-15Manufacturing (CMC) · Supplement 30 · standardAP
1984-03-01Manufacturing (CMC) · Supplement 29 · standardAP
1982-06-14Labeling · Supplement 26 · standardAP
1982-06-10Manufacturing (CMC) · Supplement 28 · standardAP
1981-11-06Manufacturing (CMC) · Supplement 27 · standardAP
1981-07-21Manufacturing (CMC) · Supplement 17 · standardAP
1980-10-01Labeling · Supplement 25 · standardAP
1980-07-02Labeling · Supplement 24 · standardAP
1980-06-16Manufacturing (CMC) · Supplement 21 · standardAP
1980-06-12Manufacturing (CMC) · Supplement 22 · standardAP
1980-06-06Manufacturing (CMC) · Supplement 23 · standardAP
1980-06-03Manufacturing (CMC) · Supplement 19 · standardAP
1980-05-23Manufacturing (CMC) · Supplement 18 · standardAP
1980-03-20Manufacturing (CMC) · Supplement 16 · standardAP
1979-10-04Manufacturing (CMC) · Supplement 13 · standardAP
1979-09-17Manufacturing (CMC) · Supplement 12 · standardAP
1979-07-31Manufacturing (CMC) · Supplement 11 · standardAP
1979-07-18Manufacturing (CMC) · Supplement 10 · standardAP
1979-05-01Manufacturing (CMC) · Supplement 9 · standardAP
1978-08-29Manufacturing (CMC) · Supplement 7 · standardAP
1978-08-18Manufacturing (CMC) · Supplement 8 · standardAP
1977-11-23Manufacturing (CMC) · Supplement 6 · standardAP
1977-07-21Manufacturing (CMC) · Supplement 1 · standardAP
1977-04-26Manufacturing (CMC) · Supplement 5 · standardAP
1977-01-05Manufacturing (CMC) · Supplement 4 · 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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