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FDA ANDA · ANDA072052
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
Sponsor: HERITAGE PHARMA
APPLICATION
ANDA072052
TYPE
ANDA
ORIGINAL APPROVAL
1988-12-16
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEDiscontinued
AMITRIPTYLINE HYDROCHLORIDE EQ 12.5MG BASE, CHLORDIAZEPOXIDE 5MG · TABLET · ORAL
Approval history
2025-06-24Labeling · Supplement 13 · standardAP
2023-01-17Labeling · Supplement 12 · standardAP
2021-02-05Labeling · Supplement 11 · standardAP
2016-12-16Labeling · Supplement 10 · standardAP
2016-04-25Labeling · Supplement 9 · standardAP
2014-12-22Labeling · Supplement 8 · standardAP
1995-12-08Labeling · Supplement 6AP
1993-11-24Labeling · Supplement 5AP
1991-05-31Manufacturing (CMC) · Supplement 3AP
1991-01-28Manufacturing (CMC) · Supplement 4AP
1990-06-29Manufacturing (CMC) · Supplement 2AP
1989-05-25Labeling · Supplement 1AP
1988-12-16OriginalAP
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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