Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075191
Company: APOTEX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PENTOXIFYLLINE PENTOXIFYLLINE 400MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No 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
06/09/1999 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75191ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/29/2017 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

07/31/2015 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

07/31/2015 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

07/31/2015 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

06/18/2001 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/2001 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/18/2001 SUPPL-4 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

06/18/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/2001 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/24/2000 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

PENTOXIFYLLINE

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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