Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011641
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIABINESE CHLORPROPAMIDE 100MG TABLET;ORAL Prescription AB Yes No
DIABINESE CHLORPROPAMIDE 250MG TABLET;ORAL Prescription AB 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
10/28/1958 ORIG-1 Approval Type 1 - New Molecular Entity 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
02/01/2011 SUPPL-66 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011641s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011641s066ltr.pdf
08/27/2009 SUPPL-65 Labeling Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011641s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/011641Orig1s065.pdf
10/27/2008 SUPPL-64 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/011641s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/011641s064ltr.pdf
01/04/2004 SUPPL-61 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11641slr061ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/011641_S061_DIABINESE_TABLETS_AP.pdf
05/16/2002 SUPPL-60 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11641s058ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/011641_058&060_Diabinese_APPROVAL_PACKAGE.pdf
12/15/1999 SUPPL-59 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/16/2002 SUPPL-58 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11641s058ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/011641_058&060_Diabinese_APPROVAL_PACKAGE.pdf
11/24/1993 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

01/28/1993 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/1987 SUPPL-55 Labeling

Label is not available on this site.

02/24/1987 SUPPL-54 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/04/1984 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

09/04/1984 SUPPL-52 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/04/1984 SUPPL-51 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/18/1984 SUPPL-50 Labeling

Label is not available on this site.

05/28/1982 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

03/03/1981 SUPPL-47 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/24/1978 SUPPL-44 Labeling

Label is not available on this site.

05/16/1978 SUPPL-43 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/01/2011 SUPPL-66 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011641s066lbl.pdf
08/27/2009 SUPPL-65 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011641s065lbl.pdf
10/27/2008 SUPPL-64 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/011641s064lbl.pdf

DIABINESE

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHLORPROPAMIDE CHLORPROPAMIDE 100MG TABLET;ORAL Prescription No AB 088921 ANI PHARMS INC
CHLORPROPAMIDE CHLORPROPAMIDE 100MG TABLET;ORAL Prescription No AB 088549 MYLAN
DIABINESE CHLORPROPAMIDE 100MG TABLET;ORAL Prescription Yes AB 011641 PFIZER

TABLET;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHLORPROPAMIDE CHLORPROPAMIDE 250MG TABLET;ORAL Prescription No AB 088922 ANI PHARMS INC
CHLORPROPAMIDE CHLORPROPAMIDE 250MG TABLET;ORAL Prescription No AB 088549 MYLAN
DIABINESE CHLORPROPAMIDE 250MG TABLET;ORAL Prescription Yes AB 011641 PFIZER
GLUCAMIDE CHLORPROPAMIDE 250MG TABLET;ORAL Prescription No AB 088641 ANI PHARMS INC

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