APPLICATION
ANDA086010
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 25MG · TABLET · ORAL
Approval history
2002-05-07Labeling · Supplement 53AP
2001-01-29Labeling · Supplement 52AP
1999-03-12Manufacturing (CMC) · Supplement 50AP
1999-03-12Manufacturing (CMC) · Supplement 51AP
1998-02-25Manufacturing (CMC) · Supplement 49AP
1998-02-05Manufacturing (CMC) · Supplement 48AP
1995-06-01Manufacturing (CMC) · Supplement 44AP
1995-06-01Labeling · Supplement 47AP
1995-06-01Manufacturing (CMC) · Supplement 45AP
1995-06-01Manufacturing (CMC) · Supplement 43AP
1995-04-24Labeling · Supplement 46AP
1993-11-24Manufacturing (CMC) · Supplement 42AP
1993-07-02Labeling · Supplement 55AP
1991-11-14Labeling · Supplement 41AP
1989-08-17Bioequivalence · Supplement 40AP
1989-08-17Bioequivalence · Supplement 39AP
1989-07-11Manufacturing (CMC) · Supplement 38AP
1989-07-11Manufacturing (CMC) · Supplement 37AP
1988-02-18Manufacturing (CMC) · Supplement 33AP
1986-07-02Manufacturing (CMC) · Supplement 32AP
1984-11-23Manufacturing (CMC) · Supplement 30AP
1984-06-15Manufacturing (CMC) · Supplement 28AP
1983-01-21Manufacturing (CMC) · Supplement 26AP
1983-01-21Manufacturing (CMC) · Supplement 27AP
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.
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