APPLICATION
ANDA070575
TYPE
ANDA
ORIGINAL APPROVAL
1986-10-14
LATEST ACTION
2001-06-14
ROUTE
INHALATION, ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
MUCOSIL-10Discontinued
ACETYLCYSTEINE 10% · SOLUTION · INHALATION, ORAL
Approval history
2001-06-14Manufacturing (CMC) · Supplement 24AP
2000-03-21Manufacturing (CMC) · Supplement 25AP
2000-03-21Manufacturing (CMC) · Supplement 26AP
1999-06-25Labeling · Supplement 23AP
1998-11-25Labeling · Supplement 20AP
1998-02-20Labeling · Supplement 19AP
1997-09-05Manufacturing (CMC) · Supplement 18AP
1996-04-24Manufacturing (CMC) · Supplement 17AP
1994-03-11Manufacturing (CMC) · Supplement 16AP
1992-06-29Labeling · Supplement 15AP
1990-10-26Labeling · Supplement 14AP
1989-08-01Manufacturing (CMC) · Supplement 13AP
1989-04-20Manufacturing (CMC) · Supplement 11AP
1988-09-29Labeling · Supplement 10AP
1988-04-20Labeling · Supplement 6AP
1987-06-16Manufacturing (CMC) · Supplement 1AP
1987-06-16Manufacturing (CMC) · Supplement 2AP
1987-06-16Manufacturing (CMC) · Supplement 3AP
1987-01-22Manufacturing (CMC) · Supplement 5AP
1986-10-14OriginalAP
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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