APPLICATION
ANDA086009
TYPE
ANDA
ORIGINAL APPROVAL
1978-04-10
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMITRIPTYLINE HYDROCHLORIDEPrescription
AMITRIPTYLINE HYDROCHLORIDE 100MG · TABLET · ORAL
AMITRIPTYLINE HYDROCHLORIDEPrescription
AMITRIPTYLINE HYDROCHLORIDE 25MG · TABLET · ORAL
AMITRIPTYLINE HYDROCHLORIDEPrescription
AMITRIPTYLINE HYDROCHLORIDE 50MG · TABLET · ORAL
AMITRIPTYLINE HYDROCHLORIDEPrescription
AMITRIPTYLINE HYDROCHLORIDE 150MG · TABLET · ORAL
AMITRIPTYLINE HYDROCHLORIDEPrescription
AMITRIPTYLINE HYDROCHLORIDE 75MG · TABLET · ORAL
AMITRIPTYLINE HYDROCHLORIDEPrescription
AMITRIPTYLINE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2025-06-24Labeling · Supplement 71 · standardAP
2016-04-25Labeling · Supplement 67 · standardAP
2014-07-17Labeling · Supplement 66 · standardAP
2008-04-14Labeling · Supplement 59AP
2007-11-21Labeling · Supplement 61AP
2007-07-11Labeling · Supplement 58AP
2005-07-08Labeling · Supplement 51AP
2002-05-07Labeling · Supplement 49AP
2001-01-29Labeling · Supplement 48AP
1999-03-12Manufacturing (CMC) · Supplement 46AP
1999-03-12Manufacturing (CMC) · Supplement 47AP
1998-02-25Manufacturing (CMC) · Supplement 45AP
1998-02-05Manufacturing (CMC) · Supplement 44AP
1995-06-01Labeling · Supplement 43AP
1995-06-01Manufacturing (CMC) · Supplement 41AP
1995-06-01Manufacturing (CMC) · Supplement 40AP
1995-06-01Manufacturing (CMC) · Supplement 39AP
1995-04-24Labeling · Supplement 42AP
1993-11-24Manufacturing (CMC) · Supplement 38AP
1993-07-02Labeling · Supplement 37AP
1991-11-14Labeling · Supplement 35AP
1989-08-17Bioequivalence · Supplement 33AP
1989-08-17Bioequivalence · Supplement 34AP
1989-07-11Manufacturing (CMC) · Supplement 31AP
1989-07-11Manufacturing (CMC) · Supplement 32AP
1988-02-18Manufacturing (CMC) · Supplement 27AP
1986-07-02Manufacturing (CMC) · Supplement 26AP
1984-11-23Manufacturing (CMC) · Supplement 24AP
1984-06-15Manufacturing (CMC) · Supplement 22AP
1983-01-19Manufacturing (CMC) · Supplement 21AP
1983-01-19Manufacturing (CMC) · Supplement 20AP
1982-05-04Manufacturing (CMC) · Supplement 17AP
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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