Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020884
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AGGRENOX ASPIRIN; DIPYRIDAMOLE 25MG;200MG CAPSULE, EXTENDED RELEASE;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
11/22/1999 ORIG-1 Approval Type 4 - New Combination PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20884_AGGRENOX_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20884_AGGRENOX_APPROV.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20884_Aggrenox.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/09/2015 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020884s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020884Orig1s035ltr.pdf
05/30/2014 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

05/29/2013 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

09/07/2012 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020884s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020884Orig1s030ltr.pdf
10/01/2009 SUPPL-18 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020884s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020884s018ltr.pdf
11/28/2006 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020884s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020884s014ltr.pdf
03/26/2007 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020884s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020884s012ltr.pdf
01/28/2004 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20884slr007ltr.pdf
06/20/2002 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/2002 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/21/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/23/2001 SUPPL-3 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20884S3ltr.pdf
10/17/2000 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/10/2001 SUPPL-1 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20884s1lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/09/2015 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020884s035lbl.pdf
09/07/2012 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020884s030lbl.pdf
10/01/2009 SUPPL-18 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020884s018lbl.pdf
03/26/2007 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020884s012lbl.pdf
11/28/2006 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020884s014lbl.pdf
08/10/2001 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20884s1lbl.pdf
11/22/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20884_AGGRENOX_prntlbl.pdf

AGGRENOX

CAPSULE, EXTENDED RELEASE;ORAL; 25MG;200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AGGRENOX ASPIRIN; DIPYRIDAMOLE 25MG;200MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 020884 BOEHRINGER INGELHEIM
ASPIRIN AND DIPYRIDAMOLE ASPIRIN; DIPYRIDAMOLE 25MG;200MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206392 AMNEAL PHARMS
ASPIRIN AND DIPYRIDAMOLE ASPIRIN; DIPYRIDAMOLE 25MG;200MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078804 BARR
ASPIRIN AND DIPYRIDAMOLE ASPIRIN; DIPYRIDAMOLE 25MG;200MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206964 IMPAX LABS INC
ASPIRIN AND DIPYRIDAMOLE ASPIRIN; DIPYRIDAMOLE 25MG;200MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 207944 PAR PHARM INC
ASPIRIN AND DIPYRIDAMOLE ASPIRIN; DIPYRIDAMOLE 25MG;200MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206739 SANDOZ INC
ASPIRIN AND DIPYRIDAMOLE ASPIRIN; DIPYRIDAMOLE 25MG;200MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206753 ZYDUS PHARMS USA INC

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