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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020482
Company: BAYER HLTHCARE

Products on NDA 020482

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PRECOSE	ACARBOSE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
PRECOSE	ACARBOSE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
PRECOSE	ACARBOSE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020482

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/06/1995	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020482Orig1s000rev.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/09/2015	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020482s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020482Orig1s027ltr.pdf
11/11/2014	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
02/29/2012	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020482s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020482s025ltr.pdf
03/24/2011	SUPPL-24	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020482s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020482s024ltr.pdf
08/23/2008	SUPPL-23	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020482s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020482s023ltr.pdf
07/29/2005	SUPPL-15	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020482s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020482s015ltr.pdf
06/27/2000	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
10/29/2002	SUPPL-11	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20482slr011ltr.pdf
08/16/1999	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020482S010_Precose_appltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020482S010_Precose.cfm
02/04/1998	SUPPL-9	Labeling		Label is not available on this site.
09/29/1998	SUPPL-8	Efficacy-New Indication	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20482s7-8ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020482a_s007_s008.pdf
09/29/1998	SUPPL-7	Efficacy-New Indication	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20482s7-8ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020482a_s007_s008.pdf
11/20/1997	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
10/10/1997	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
05/29/1997	SUPPL-4	Manufacturing (CMC)-Formulation		Label is not available on this site.
12/13/1996	SUPPL-3	Labeling		Label is not available on this site.
01/16/1996	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 020482

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/09/2015	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020482s027lbl.pdf
02/29/2012	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020482s025lbl.pdf
03/24/2011	SUPPL-24	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020482s024lbl.pdf
08/23/2008	SUPPL-23	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020482s023lbl.pdf
07/29/2005	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020482s015lbl.pdf

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