Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008678
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISONIAZID ISONIAZID 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
ISONIAZID ISONIAZID 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
11/17/1952 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
07/13/2016 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008678s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008678Orig1s028ltr.pdf
04/23/2007 SUPPL-26 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/008678s025,s026ini.pdf
04/23/2007 SUPPL-25 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/008678s025,s026ini.pdf
07/13/2000 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/07/2000 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

03/06/1997 SUPPL-21 Labeling

Label is not available on this site.

11/21/1995 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/01/1996 SUPPL-19 Labeling

Label is not available on this site.

08/10/1992 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

08/10/1992 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/23/1988 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/09/1985 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/10/1987 SUPPL-14 Labeling

Label is not available on this site.

01/04/1984 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

08/19/1983 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

08/19/1983 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

03/28/1983 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/28/1983 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1980 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/13/2016 SUPPL-28 Labeling-Package Insert Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008678s028lbl.pdf

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