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FDA ANDA · ANDA071297

CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE

Sponsor: MYLAN PHARMS INC

APPLICATION
ANDA071297
TYPE
ANDA
ORIGINAL APPROVAL
1986-12-10
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEPrescription
AMITRIPTYLINE HYDROCHLORIDE EQ 25MG BASE, CHLORDIAZEPOXIDE 10MG · TABLET · ORAL
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEPrescription
AMITRIPTYLINE HYDROCHLORIDE EQ 12.5MG BASE, CHLORDIAZEPOXIDE 5MG · TABLET · ORAL

Approval history

2025-06-24Labeling · Supplement 44 · standardAP
2025-06-24Labeling · Supplement 43 · standardAP
2023-01-13Labeling · Supplement 40 · standardAP
2022-07-06Labeling · Supplement 38 · standardAP
2021-02-05Labeling · Supplement 36 · standardAP
2021-02-01Labeling · Supplement 33 · standardAP
2016-12-16Labeling · Supplement 32 · standardAP
2016-04-25Labeling · Supplement 31 · standardAP
2014-07-17Labeling · Supplement 30 · standard — Label ↗AP
2008-02-20Labeling · Supplement 26 — Letter ↗AP
2007-07-11Labeling · Supplement 25 — Label ↗AP
2005-10-06Labeling · Supplement 21AP
2000-11-07Labeling · Supplement 18AP
1998-04-03Manufacturing (CMC) · Supplement 16AP
1998-02-05Manufacturing (CMC) · Supplement 17AP
1995-06-28Labeling · Supplement 15AP
1994-03-31Labeling · Supplement 11AP
1994-03-31Manufacturing (CMC) · Supplement 10AP
1993-09-29Manufacturing (CMC) · Supplement 12AP
1993-05-28Labeling · Supplement 13AP
1989-08-16Manufacturing (CMC) · Supplement 9AP
1989-06-12Labeling · Supplement 8AP
1989-04-26Manufacturing (CMC) · Supplement 6AP
1988-04-19Labeling · Supplement 5AP
1988-04-08Manufacturing (CMC) · Supplement 4AP
1988-04-08Manufacturing (CMC) · Supplement 3AP
1987-04-13Manufacturing (CMC) · Supplement 2AP
1987-04-13Manufacturing (CMC) · Supplement 1AP
1986-12-10OriginalAP
VIEW ON DRUGS@FDA ↗

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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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