Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017425
Company: TEVA BRANDED PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROGLYCEM DIAZOXIDE 50MG CAPSULE;ORAL Discontinued None No No
PROGLYCEM DIAZOXIDE 100MG 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
05/28/1976 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2015 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017425s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017425Orig1s016,017453s020ltr.pdf
01/17/1997 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/24/1996 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

06/30/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/28/1989 SUPPL-12 Labeling

Label is not available on this site.

09/06/1988 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

05/14/1987 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/20/1986 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1985 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/02/1983 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

12/14/1982 SUPPL-4 Labeling

Label is not available on this site.

07/09/1980 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

07/09/1980 SUPPL-2 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/07/1979 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
09/18/2015 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017425s016lbl.pdf

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