APPLICATION
ANDA086011
TYPE
ANDA
ORIGINAL APPROVAL
1978-04-10
LATEST ACTION
2002-05-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMITRIPTYLINE HYDROCHLORIDEPrescription
AMITRIPTYLINE HYDROCHLORIDE 75MG · TABLET · ORAL
Approval history
2002-05-07Labeling · Supplement 41AP
2001-01-29Labeling · Supplement 40AP
1999-03-12Manufacturing (CMC) · Supplement 39AP
1999-03-12Manufacturing (CMC) · Supplement 38AP
1998-02-25Manufacturing (CMC) · Supplement 37AP
1998-02-05Manufacturing (CMC) · Supplement 36AP
1995-06-01Labeling · Supplement 35AP
1995-06-01Manufacturing (CMC) · Supplement 33AP
1995-06-01Manufacturing (CMC) · Supplement 31AP
1995-06-01Manufacturing (CMC) · Supplement 32AP
1995-04-24Labeling · Supplement 34AP
1993-11-24Manufacturing (CMC) · Supplement 30AP
1993-07-02Labeling · Supplement 29AP
1991-11-14Labeling · Supplement 27AP
1990-12-28Labeling · Supplement 26AP
1990-01-31Manufacturing (CMC) · Supplement 25AP
1988-02-18Manufacturing (CMC) · Supplement 21AP
1986-07-02Manufacturing (CMC) · Supplement 20AP
1985-03-05Manufacturing (CMC) · Supplement 19AP
1984-11-23Manufacturing (CMC) · Supplement 17AP
1984-06-15Manufacturing (CMC) · Supplement 15AP
1983-01-21Manufacturing (CMC) · Supplement 13AP
1983-01-21Manufacturing (CMC) · Supplement 14AP
1978-04-10OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.