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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011641
Company: PFIZER

Products on NDA 011641

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIABINESE	CHLORPROPAMIDE	100MG	TABLET;ORAL	Discontinued	None	Yes	No
DIABINESE	CHLORPROPAMIDE	250MG	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 011641

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.

Labels for NDA 011641

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

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