APPLICATION
ANDA089884
TYPE
ANDA
ORIGINAL APPROVAL
1998-10-30
LATEST ACTION
2001-06-14
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
NITROGLYCERINPrescription
NITROGLYCERIN 0.2MG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
Approval history
2001-06-14Manufacturing (CMC) · Supplement 3AP
2001-06-14Manufacturing (CMC) · Supplement 4AP
2001-06-14Manufacturing (CMC) · Supplement 2AP
2000-08-21Labeling · Supplement 1AP
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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