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FDA ANDA · ANDA211925
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
Sponsor: MICRO LABS
APPLICATION
ANDA211925
TYPE
ANDA
ORIGINAL APPROVAL
2022-02-02
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEDiscontinued
AMITRIPTYLINE HYDROCHLORIDE EQ 25MG BASE, CHLORDIAZEPOXIDE 10MG · TABLET · ORAL
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEDiscontinued
AMITRIPTYLINE HYDROCHLORIDE EQ 12.5MG BASE, CHLORDIAZEPOXIDE 5MG · TABLET · ORAL
Approval history
2025-06-24Labeling · Supplement 4 · standardAP
2025-06-17Labeling · Supplement 2 · standardAP
2023-01-17Labeling · Supplement 1 · standardAP
2022-02-02UNKNOWN · Original · standardAP
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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