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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017453
Company: TEVA BRANDED PHARM

Products on NDA 017453

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROGLYCEM	DIAZOXIDE	50MG/ML	SUSPENSION;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017453

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-23	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
05/13/2016	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
09/18/2015	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017453s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017425Orig1s016,017453s020ltr.pdf
11/21/2013	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
12/17/2008	SUPPL-14	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017453s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017453s014ltr.pdf
01/21/2004	SUPPL-10	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17453scm010ltr.pdf
07/28/1989	SUPPL-8	Labeling		Label is not available on this site.
05/14/1987	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
02/24/1987	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/04/1984	SUPPL-5	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
12/14/1982	SUPPL-4	Labeling		Label is not available on this site.
06/23/1981	SUPPL-3	Manufacturing (CMC)-Packaging		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 017453

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2022	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017425s017,017453s023lbl.pdf
09/18/2015	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017453s020lbl.pdf
12/17/2008	SUPPL-14	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017453s014lbl.pdf
12/17/2008	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017453s014lbl.pdf

Therapeutic Equivalents for NDA 017453

PROGLYCEM

SUSPENSION;ORAL; 50MG/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIAZOXIDE	DIAZOXIDE	50MG/ML	SUSPENSION;ORAL	Prescription	No	AB	211050	E5 PHARMA INC
DIAZOXIDE	DIAZOXIDE	50MG/ML	SUSPENSION;ORAL	Prescription	No	AB	210799	NOVITIUM PHARMA
PROGLYCEM	DIAZOXIDE	50MG/ML	SUSPENSION;ORAL	Prescription	Yes	AB	017453	TEVA BRANDED PHARM

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