APPLICATION
ANDA087355
TYPE
ANDA
ORIGINAL APPROVAL
1981-05-28
LATEST ACTION
2020-06-25
ROUTE
TOPICAL, TRANSDERMAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription
Products
NITROGLYCERIN · ReferencePrescription
NITROGLYCERIN 2% · OINTMENT · TRANSDERMAL
Approval history
2020-06-25Labeling · Supplement 33 · standardAP
2005-10-05Labeling · Supplement 26AP
2004-08-06Labeling · Supplement 25AP
1999-08-31Labeling · Supplement 23AP
1999-06-09Manufacturing (CMC) · Supplement 22AP
1999-04-26Manufacturing (CMC) · Supplement 18AP
1999-04-26Labeling · Supplement 19AP
1999-04-26Manufacturing (CMC) · Supplement 17AP
1996-03-07Manufacturing (CMC) · Supplement 16AP
1993-09-30Manufacturing (CMC) · Supplement 13AP
1993-04-05Labeling · Supplement 15AP
1992-01-31Labeling · Supplement 14AP
1991-10-22Labeling · Supplement 12AP
1989-03-20Manufacturing (CMC) · Supplement 11AP
1987-07-31Manufacturing (CMC) · Supplement 9AP
1987-07-31Manufacturing (CMC) · Supplement 10AP
1986-12-15Manufacturing (CMC) · Supplement 7AP
1984-02-01Manufacturing (CMC) · Supplement 2AP
1984-02-01Manufacturing (CMC) · Supplement 3AP
1981-05-28OriginalAP
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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