Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020482
Company: BAYER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRECOSE ACARBOSE 50MG TABLET;ORAL Prescription AB Yes No
PRECOSE ACARBOSE 100MG TABLET;ORAL Prescription AB Yes No
PRECOSE ACARBOSE 25MG 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
09/06/1995 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

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.

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

PRECOSE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACARBOSE ACARBOSE 50MG TABLET;ORAL Prescription No AB 202271 EMCURE PHARMS LTD
ACARBOSE ACARBOSE 50MG TABLET;ORAL Prescription No AB 078441 IMPAX LABS
ACARBOSE ACARBOSE 50MG TABLET;ORAL Prescription No AB 091053 MYLAN
ACARBOSE ACARBOSE 50MG TABLET;ORAL Prescription No AB 090912 STRIDES PHARMA
ACARBOSE ACARBOSE 50MG TABLET;ORAL Prescription No AB 091343 VIRTUS PHARM
ACARBOSE ACARBOSE 50MG TABLET;ORAL Prescription No AB 077532 WATSON LABS
ACARBOSE ACARBOSE 50MG TABLET;ORAL Prescription No AB 078470 WEST-WARD PHARMS INT
PRECOSE ACARBOSE 50MG TABLET;ORAL Prescription Yes AB 020482 BAYER HLTHCARE

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACARBOSE ACARBOSE 100MG TABLET;ORAL Prescription No AB 202271 EMCURE PHARMS LTD
ACARBOSE ACARBOSE 100MG TABLET;ORAL Prescription No AB 078441 IMPAX LABS
ACARBOSE ACARBOSE 100MG TABLET;ORAL Prescription No AB 091053 MYLAN
ACARBOSE ACARBOSE 100MG TABLET;ORAL Prescription No AB 090912 STRIDES PHARMA
ACARBOSE ACARBOSE 100MG TABLET;ORAL Prescription No AB 091343 VIRTUS PHARM
ACARBOSE ACARBOSE 100MG TABLET;ORAL Prescription No AB 077532 WATSON LABS
ACARBOSE ACARBOSE 100MG TABLET;ORAL Prescription No AB 078470 WEST-WARD PHARMS INT
PRECOSE ACARBOSE 100MG TABLET;ORAL Prescription Yes AB 020482 BAYER HLTHCARE

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACARBOSE ACARBOSE 25MG TABLET;ORAL Prescription No AB 202271 EMCURE PHARMS LTD
ACARBOSE ACARBOSE 25MG TABLET;ORAL Prescription No AB 078441 IMPAX LABS
ACARBOSE ACARBOSE 25MG TABLET;ORAL Prescription No AB 091053 MYLAN
ACARBOSE ACARBOSE 25MG TABLET;ORAL Prescription No AB 090912 STRIDES PHARMA
ACARBOSE ACARBOSE 25MG TABLET;ORAL Prescription No AB 091343 VIRTUS PHARM
ACARBOSE ACARBOSE 25MG TABLET;ORAL Prescription No AB 077532 WATSON LABS
ACARBOSE ACARBOSE 25MG TABLET;ORAL Prescription No AB 078470 WEST-WARD PHARMS INT
PRECOSE ACARBOSE 25MG TABLET;ORAL Prescription Yes AB 020482 BAYER HLTHCARE

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