APPLICATION
ANDA086153
TYPE
ANDA
ORIGINAL APPROVAL
1978-04-26
LATEST ACTION
2002-05-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMITRIPTYLINE HYDROCHLORIDEPrescription
AMITRIPTYLINE HYDROCHLORIDE 150MG · TABLET · ORAL
Approval history
2002-05-07Labeling · Supplement 39AP
2001-01-29Labeling · Supplement 38AP
1999-03-12Manufacturing (CMC) · Supplement 37AP
1999-03-12Manufacturing (CMC) · Supplement 36AP
1998-02-25Manufacturing (CMC) · Supplement 35AP
1998-02-05Manufacturing (CMC) · Supplement 34AP
1995-06-01Manufacturing (CMC) · Supplement 29AP
1995-06-01Labeling · Supplement 33AP
1995-06-01Manufacturing (CMC) · Supplement 31AP
1995-06-01Manufacturing (CMC) · Supplement 30AP
1995-04-24Labeling · Supplement 32AP
1993-11-24Manufacturing (CMC) · Supplement 28AP
1993-07-02Labeling · Supplement 27AP
1991-11-14Labeling · Supplement 25AP
1990-01-31Manufacturing (CMC) · Supplement 24AP
1988-02-18Manufacturing (CMC) · Supplement 20AP
1986-07-02Manufacturing (CMC) · Supplement 19AP
1984-06-15Manufacturing (CMC) · Supplement 15AP
1983-01-19Manufacturing (CMC) · Supplement 13AP
1983-01-19Manufacturing (CMC) · Supplement 14AP
1978-04-26OriginalAP
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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