APPLICATION
NDA014713
TYPE
NDA
ORIGINAL APPROVAL
1969-09-17
LATEST ACTION
2002-05-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ETRAFON-FORTEDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 25MG, PERPHENAZINE 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ETRAFON 2-25Discontinued
AMITRIPTYLINE HYDROCHLORIDE 25MG, PERPHENAZINE 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ETRAFON-ADiscontinued
AMITRIPTYLINE HYDROCHLORIDE 10MG, PERPHENAZINE 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ETRAFON 2-10Discontinued
AMITRIPTYLINE HYDROCHLORIDE 10MG, PERPHENAZINE 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2001-03-02Manufacturing (CMC) · Supplement 30 · standardAP
2000-08-23Labeling · Supplement 23 · standardAP
2000-08-23Labeling · Supplement 24 · standardAP
2000-08-18Manufacturing (CMC) · Supplement 29 · standardAP
2000-05-23Manufacturing (CMC) · Supplement 26 · standardAP
2000-03-03Manufacturing (CMC) · Supplement 28 · standardAP
1999-09-10Manufacturing (CMC) · Supplement 27 · standardAP
1998-08-21Manufacturing (CMC) · Supplement 25 · standardAP
1988-08-03Manufacturing (CMC) · Supplement 20 · standardAP
1984-12-07Manufacturing (CMC) · Supplement 18 · standardAP
1984-08-15Manufacturing (CMC) · Supplement 17 · standardAP
1981-02-17Manufacturing (CMC) · Supplement 14 · standardAP
1980-02-14Manufacturing (CMC) · Supplement 12 · standardAP
1980-01-29Manufacturing (CMC) · Supplement 11 · standardAP
1979-02-06Labeling · Supplement 10 · standardAP
1969-09-17Type 5 - New Formulation or New Manufacturer · Original · standard — Other Important Information from FDA ↗AP
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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