Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071296
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE EQ 12.5MG BASE;5MG TABLET; ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/10/1986 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/07/2000 SUPPL-18 Labeling

Label is not available on this site.

02/05/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/03/1998 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/28/1995 SUPPL-15 Labeling

Label is not available on this site.

05/28/1993 SUPPL-13 Labeling

Label is not available on this site.

09/29/1993 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/31/1994 SUPPL-11 Labeling

Label is not available on this site.

03/31/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/16/1989 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/12/1989 SUPPL-8 Labeling

Label is not available on this site.

04/26/1989 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/18/1988 SUPPL-5 Labeling

Label is not available on this site.

04/08/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/08/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/13/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/13/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE

TABLET; ORAL; EQ 12.5MG BASE;5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE EQ 12.5MG BASE;5MG TABLET; ORAL Prescription No AB 071296 MYLAN

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