Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017453
Company: TEVA BRANDED PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROGLYCEM DIAZOXIDE 50MG/ML SUSPENSION;ORAL Prescription None Yes Yes
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
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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