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FDA ANDA · ANDA071063
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Sponsor: FOSUN PHARMA
APPLICATION
ANDA071063
TYPE
ANDA
ORIGINAL APPROVAL
1987-11-27
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 25MG, PERPHENAZINE 2MG · TABLET · ORAL
Approval history
2025-06-24Labeling · Supplement 27 · standardAP
2025-01-22Labeling · Supplement 26 · standardAP
2017-02-23Labeling · Supplement 25 · standardAP
2016-04-25Labeling · Supplement 24 · standardAP
2015-01-17Labeling · Supplement 23 · standardAP
2014-07-18Labeling · Supplement 22 · standardAP
2012-12-06Labeling · Supplement 21AP
2002-12-16Manufacturing (CMC) · Supplement 16AP
2001-08-08Manufacturing (CMC) · Supplement 15AP
2001-04-02Manufacturing (CMC) · Supplement 14AP
2000-04-03Manufacturing (CMC) · Supplement 13AP
1999-10-07Manufacturing (CMC) · Supplement 12AP
1999-05-05Manufacturing (CMC) · Supplement 11AP
1999-04-13Manufacturing (CMC) · Supplement 9AP
1999-04-13Labeling · Supplement 10AP
1997-10-28Manufacturing (CMC) · Supplement 8AP
1996-12-05Manufacturing (CMC) · Supplement 7AP
1996-04-26Manufacturing (CMC) · Supplement 6AP
1995-04-10Labeling · Supplement 5AP
1994-01-24Manufacturing (CMC) · Supplement 4AP
1993-06-29Labeling · Supplement 3AP
1988-09-09Labeling · Supplement 2AP
1987-11-27OriginalAP
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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