APPLICATION
NDA014715
TYPE
NDA
ORIGINAL APPROVAL
1965-08-23
LATEST ACTION
2009-03-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TRIAVIL 4-25Discontinued
AMITRIPTYLINE HYDROCHLORIDE 25MG, PERPHENAZINE 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TRIAVIL 4-10Discontinued
AMITRIPTYLINE HYDROCHLORIDE 10MG, PERPHENAZINE 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TRIAVIL 4-50Discontinued
AMITRIPTYLINE HYDROCHLORIDE 50MG, PERPHENAZINE 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TRIAVIL 2-10Discontinued
AMITRIPTYLINE HYDROCHLORIDE 10MG, PERPHENAZINE 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TRIAVIL 2-25Discontinued
AMITRIPTYLINE HYDROCHLORIDE 25MG, PERPHENAZINE 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2009-03-13Labeling · Supplement 71AP
2009-03-13Labeling · Supplement 53AP
2009-03-13Labeling · Supplement 29AP
2009-03-13Labeling · Supplement 43AP
2009-03-13Labeling · Supplement 35AP
2009-03-13Labeling · Supplement 33AP
2009-03-13Labeling · Supplement 31AP
2009-03-13Labeling · Supplement 76AP
2009-03-13Labeling · Supplement 80 · standardAP
2009-03-13Labeling · Supplement 58AP
2009-03-13Labeling · Supplement 72AP
2009-03-13Labeling · Supplement 56AP
2009-03-13Labeling · Supplement 42AP
2009-03-13Labeling · Supplement 26AP
2009-03-13Labeling · Supplement 69AP
1994-12-28Manufacturing (CMC) · Supplement 79 · standardAP
1994-07-07Manufacturing (CMC) · Supplement 78 · standardAP
1989-08-07Manufacturing (CMC) · Supplement 77 · standardAP
1989-03-28Manufacturing (CMC) · Supplement 73 · standardAP
1988-08-09Manufacturing (CMC) · Supplement 75 · standardAP
1988-04-08Manufacturing (CMC) · Supplement 74 · standardAP
1986-07-25Manufacturing (CMC) · Supplement 61 · standardAP
1985-12-05Labeling · Supplement 68AP
1985-08-06Labeling · Supplement 65AP
1985-08-06Labeling · Supplement 66AP
1985-08-06Labeling · Supplement 67AP
1984-09-13Manufacturing (CMC) · Supplement 64 · standardAP
1984-05-21Labeling · Supplement 57AP
1984-05-14Manufacturing (CMC) · Supplement 62 · standardAP
1984-04-23Manufacturing (CMC) · Supplement 45 · standardAP
1983-05-20Manufacturing (CMC) · Supplement 59 · standardAP
1983-03-15Labeling · Supplement 60AP
1981-06-25Manufacturing (CMC) · Supplement 54 · standardAP
1981-03-09Manufacturing (CMC) · Supplement 32 · standardAP
1981-03-03Manufacturing (CMC) · Supplement 48 · standardAP
1981-03-02Manufacturing (CMC) · Supplement 49 · standardAP
1981-03-02Manufacturing (CMC) · Supplement 46 · standardAP
1980-11-07Labeling · Supplement 52AP
1980-06-23Labeling · Supplement 51AP
1980-02-11Labeling · Supplement 47AP
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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