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FDA ANDA · ANDA071296

CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE

Sponsor: MYLAN

APPLICATION
ANDA071296
TYPE
ANDA
ORIGINAL APPROVAL
1986-12-10
LATEST ACTION
2000-11-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2000-11-07Labeling · Supplement 18AP
1998-04-03Manufacturing (CMC) · Supplement 16AP
1998-02-05Manufacturing (CMC) · Supplement 17AP
1995-06-28Labeling · Supplement 15AP
1994-03-31Manufacturing (CMC) · Supplement 10AP
1994-03-31Labeling · Supplement 11AP
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
1988-04-18Labeling · 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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