Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019508
Company: SMITHKLINE BEECHAM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AXID NIZATIDINE 150MG CAPSULE;ORAL Discontinued None No No
AXID NIZATIDINE 300MG CAPSULE;ORAL Discontinued 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
04/12/1988 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/24/2006 SUPPL-34 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019508s034ltr.pdf
12/23/2005 SUPPL-33 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019508s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019508s033rev2.pdf
03/02/2001 SUPPL-30 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19508S30LTR.PDF
06/19/1998 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

01/19/1999 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/22/1996 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

10/13/1998 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

10/08/1996 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/23/1996 SUPPL-23 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/02/1995 SUPPL-22 Labeling

Label is not available on this site.

08/31/1995 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/13/1993 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/13/1993 SUPPL-18 Labeling

Label is not available on this site.

11/25/1991 SUPPL-17 Labeling

Label is not available on this site.

09/21/1993 SUPPL-16 Efficacy-New Indication

Label is not available on this site.

11/25/1991 SUPPL-15 Labeling

Label is not available on this site.

04/11/1991 SUPPL-14 Labeling

Label is not available on this site.

04/10/1990 SUPPL-13 Labeling

Label is not available on this site.

07/26/1991 SUPPL-12 Efficacy-New Indication

Label is not available on this site.

08/29/1990 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

06/09/1992 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/21/1989 SUPPL-6 Labeling

Label is not available on this site.

08/29/1990 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/1989 SUPPL-4 Labeling

Label is not available on this site.

02/23/1989 SUPPL-3 Labeling

Label is not available on this site.

02/06/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/20/1988 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/23/2005 SUPPL-33 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019508s033lbl.pdf

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