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FDA ANDA · ANDA073010
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Sponsor: CHARTWELL RX
APPLICATION
ANDA073010
TYPE
ANDA
ORIGINAL APPROVAL
1991-10-17
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 25MG, PERPHENAZINE 4MG · TABLET · ORAL
Approval history
2025-06-24Labeling · Supplement 29 · standardAP
2025-01-22Labeling · Supplement 28 · standardAP
2017-02-23Labeling · Supplement 27 · standardAP
2016-04-25Labeling · Supplement 26 · standardAP
2015-11-03Labeling · Supplement 23AP
2015-01-16Labeling · Supplement 25 · standardAP
2014-07-17Labeling · Supplement 24 · standardAP
2001-04-25Labeling · Supplement 22AP
2001-04-12Manufacturing (CMC) · Supplement 20AP
2001-02-28Labeling · Supplement 21AP
2000-03-21Manufacturing (CMC) · Supplement 18AP
1999-05-07Manufacturing (CMC) · Supplement 17AP
1998-06-16Manufacturing (CMC) · Supplement 13AP
1998-06-16Labeling · Supplement 16AP
1998-06-16Manufacturing (CMC) · Supplement 14AP
1997-07-08Manufacturing (CMC) · Supplement 11AP
1997-03-26Manufacturing (CMC) · Supplement 5AP
1997-03-26Manufacturing (CMC) · Supplement 3AP
1997-03-26Manufacturing (CMC) · Supplement 6AP
1997-03-26Manufacturing (CMC) · Supplement 4AP
1996-12-31Manufacturing (CMC) · Supplement 9AP
1996-12-31Manufacturing (CMC) · Supplement 8AP
1996-04-29Labeling · Supplement 7AP
1995-08-29Labeling · Supplement 2AP
1993-08-31Labeling · Supplement 1AP
1991-10-17OriginalAP
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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