APPLICATION
NDA016012
TYPE
NDA
ORIGINAL APPROVAL
1967-09-27
LATEST ACTION
2014-07-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
VIVACTILDiscontinued
PROTRIPTYLINE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
VIVACTILDiscontinued
PROTRIPTYLINE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2000-04-11Labeling · Supplement 52 · standardAP
2000-04-11Labeling · Supplement 50 · standardAP
2000-04-11Labeling · Supplement 51 · standardAP
2000-03-27Labeling · Supplement 46 · standardAP
2000-03-27Labeling · Supplement 44 · standardAP
1998-11-04Manufacturing (CMC) · Supplement 49 · standardAP
1997-12-04Manufacturing (CMC) · Supplement 48 · standardAP
1996-12-27Manufacturing (CMC) · Supplement 47 · standardAP
1996-04-15Manufacturing (CMC) · Supplement 45 · standardAP
1994-06-01Manufacturing (CMC) · Supplement 43 · standardAP
1993-08-26Manufacturing (CMC) · Supplement 42 · standardAP
1988-04-08Manufacturing (CMC) · Supplement 41 · standardAP
1988-03-18Manufacturing (CMC) · Supplement 39 · standardAP
1987-04-13Labeling · Supplement 40AP
1986-01-21Labeling · Supplement 37AP
1985-09-20Labeling · Supplement 36AP
1984-07-16Labeling · Supplement 35AP
1983-06-09Manufacturing (CMC) · Supplement 34 · standardAP
1983-05-05Manufacturing (CMC) · Supplement 19 · standardAP
1982-02-18Labeling · Supplement 32AP
1981-03-10Manufacturing (CMC) · Supplement 28 · standardAP
1981-03-10Manufacturing (CMC) · Supplement 29 · standardAP
1981-03-06Labeling · Supplement 30AP
1980-05-12Labeling · Supplement 27AP
1980-01-29Manufacturing (CMC) · Supplement 26 · standardAP
1978-01-25Manufacturing (CMC) · Supplement 24 · standardAP
1977-03-29Manufacturing (CMC) · Supplement 21 · standardAP
1967-09-27Type 1 - New Molecular Entity · 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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