Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074962
Company: UPSHER SMITH LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PENTOXIL PENTOXIFYLLINE 400MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No 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
03/31/1999 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-962_Pentoxifylline_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74962ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-962_pentoxifylline.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/30/2005 SUPPL-8 Labeling

Label is not available on this site.

10/29/2004 SUPPL-5 Labeling

Label is not available on this site.

12/19/2002 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

04/21/2000 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

04/21/2000 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/31/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-962_Pentoxifylline_prntlbl.pdf

PENTOXIL

TABLET, EXTENDED RELEASE;ORAL; 400MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PENTOXIFYLLINE PENTOXIFYLLINE 400MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075191 APOTEX
PENTOXIFYLLINE PENTOXIFYLLINE 400MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075028 VALEANT PHARMS
PENTOXIL PENTOXIFYLLINE 400MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 074962 UPSHER SMITH LABS

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