APPLICATION
ANDA089400
TYPE
ANDA
ORIGINAL APPROVAL
1987-07-14
LATEST ACTION
2007-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMITRIPTYLINE HYDROCHLORIDEPrescription
AMITRIPTYLINE HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2007-11-21Labeling · Supplement 32AP
2007-07-16Labeling · Supplement 30AP
2007-06-29Labeling · Supplement 31AP
2005-08-26Labeling · Supplement 24AP
2005-05-05Labeling · Supplement 23AP
2002-09-30Manufacturing (CMC) · Supplement 15AP
2001-08-22Labeling · Supplement 13AP
2001-07-05Manufacturing (CMC) · Supplement 12AP
2001-03-22Manufacturing (CMC) · Supplement 11AP
2000-05-16Manufacturing (CMC) · Supplement 10AP
2000-05-16Manufacturing (CMC) · Supplement 9AP
1997-12-05Manufacturing (CMC) · Supplement 8AP
1997-02-24Manufacturing (CMC) · Supplement 7AP
1995-08-22Labeling · Supplement 6AP
1995-06-22Manufacturing (CMC) · Supplement 5AP
1994-01-12Manufacturing (CMC) · Supplement 4AP
1993-08-16Labeling · Supplement 3AP
1992-05-15Labeling · Supplement 2AP
1992-02-27Manufacturing (CMC) · Supplement 1AP
1987-07-14OriginalAP
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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