Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018631
Company: US PHARM HOLDINGS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRENTAL PENTOXIFYLLINE 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/30/1984 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
01/15/2016 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018631s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018631Orig1s041ltr.pdf
02/13/2015 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018631s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018631Orig1s040ltr.pdf
07/05/2012 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018631s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018631s039ltr.pdf
04/17/2014 SUPPL-36 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018631Orig1s036ltr.pdf
04/07/2005 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018631s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018631s034ltr.pdf
09/30/2003 SUPPL-33 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18631slr033ltr.pdf
11/03/1997 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

04/29/1997 SUPPL-30 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/018631_s030ap.pdf
06/18/1996 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

02/09/1996 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

01/02/1996 SUPPL-26 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/10/1995 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/1995 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/28/1995 SUPPL-23 Labeling

Label is not available on this site.

07/25/1994 SUPPL-22 Labeling

Label is not available on this site.

11/04/1994 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

11/24/1993 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

02/11/1993 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

12/16/1991 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/30/1991 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/27/1991 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/1991 SUPPL-14 Labeling

Label is not available on this site.

10/30/1990 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/1991 SUPPL-12 Labeling

Label is not available on this site.

02/23/1990 SUPPL-11 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/28/1989 SUPPL-9 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/27/1988 SUPPL-7 Labeling

Label is not available on this site.

09/03/1987 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/27/1986 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/24/1986 SUPPL-3 Labeling

Label is not available on this site.

10/04/1985 SUPPL-2 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/13/1985 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
01/15/2016 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018631s041lbl.pdf
02/13/2015 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018631s040lbl.pdf
07/05/2012 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018631s039lbl.pdf
04/07/2005 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018631s034lbl.pdf

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