Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071297
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE EQ 25MG BASE;10MG TABLET;ORAL Prescription None No Yes
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE EQ 12.5MG BASE;5MG TABLET;ORAL Prescription None 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
12/16/2016 SUPPL-32 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/25/2016 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

07/17/2014 SUPPL-30 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/071297s030lbl.pdf
02/20/2008 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/071297Orig1s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/071297Orig1s026ltr.pdf
07/11/2007 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/071297Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/071297Orig1s025ltr.pdf
10/06/2005 SUPPL-21 Labeling

Label is not available on this site.

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.

04/19/1988 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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/17/2014 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/071297s030lbl.pdf
02/20/2008 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/071297Orig1s026lbl.pdf
07/11/2007 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/071297Orig1s025lbl.pdf

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