APPLICATION
NDA012703
TYPE
NDA
ORIGINAL APPROVAL
1961-04-07
LATEST ACTION
2003-07-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ELAVIL · ReferenceDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ELAVIL · ReferenceDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ELAVIL · ReferenceDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ELAVIL · ReferenceDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ELAVIL · ReferenceDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ELAVIL · ReferenceDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2001-01-22Manufacturing (CMC) · Supplement 91 · priorityAP
2000-04-05Labeling · Supplement 88 · priorityAP
2000-04-05Labeling · Supplement 86 · priorityAP
2000-04-05Labeling · Supplement 84 · priorityAP
2000-04-05Labeling · Supplement 90 · priorityAP
1998-12-24Manufacturing (CMC) · Supplement 89 · priorityAP
1996-12-30Manufacturing (CMC) · Supplement 87 · priorityAP
1995-07-13Manufacturing (CMC) · Supplement 85 · priorityAP
1994-06-01Manufacturing (CMC) · Supplement 83 · priorityAP
1994-06-01Manufacturing (CMC) · Supplement 82 · priorityAP
1991-06-24Labeling · Supplement 79 · priorityAP
1991-06-24Labeling · Supplement 81 · priorityAP
1991-06-24Labeling · Supplement 76 · priorityAP
1989-07-28Manufacturing (CMC) · Supplement 80 · priorityAP
1988-12-12Manufacturing (CMC) · Supplement 77 · priorityAP
1988-04-08Manufacturing (CMC) · Supplement 78 · priorityAP
1988-02-26Manufacturing (CMC) · Supplement 75 · priorityAP
1986-07-10Labeling · Supplement 73 · priorityAP
1986-04-02Manufacturing (CMC) · Supplement 74 · priorityAP
1985-09-20Labeling · Supplement 72 · priorityAP
1984-09-13Manufacturing (CMC) · Supplement 71 · priorityAP
1984-08-15Manufacturing (CMC) · Supplement 70 · priorityAP
1984-05-21Labeling · Supplement 65 · priorityAP
1984-03-07Manufacturing (CMC) · Supplement 69 · priorityAP
1983-05-26Manufacturing (CMC) · Supplement 67 · priorityAP
1983-05-03Manufacturing (CMC) · Supplement 64 · priorityAP
1983-03-15Labeling · Supplement 68 · priorityAP
1981-09-04Manufacturing (CMC) · Supplement 57 · priorityAP
1981-06-25Manufacturing (CMC) · Supplement 62 · priorityAP
1981-03-23Labeling · Supplement 61 · priorityAP
1981-03-09Manufacturing (CMC) · Supplement 32 · priorityAP
1981-03-02Manufacturing (CMC) · Supplement 58 · priorityAP
1981-03-02Manufacturing (CMC) · Supplement 56 · priorityAP
1981-03-02Manufacturing (CMC) · Supplement 50 · priorityAP
1980-09-03Labeling · Supplement 60 · priorityAP
1980-06-23Labeling · Supplement 59 · priorityAP
1980-03-04Labeling · Supplement 54 · priorityAP
1980-01-29Manufacturing (CMC) · Supplement 49 · priorityAP
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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