An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 017425
Company: TEVA BRANDED PHARM

Products on NDA 017425

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017425

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
12/22/2022	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017425s017,017453s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/017425Orig1s017;017453Orig1s023ltr.pdf
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.

Labels for NDA 017425

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2022	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017425s017,017453s023lbl.pdf
09/18/2015	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017425s016lbl.pdf

Top