Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074874
Company: PLIVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PENTOXIFYLLINE PENTOXIFYLLINE 400MG TABLET, EXTENDED RELEASE;ORAL Discontinued None 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
05/25/1999 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74874ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/18/2002 SUPPL-8 Labeling

Label is not available on this site.

11/18/2002 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

11/18/2002 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/18/2002 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/18/2002 SUPPL-4 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

11/18/2002 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

07/07/2000 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

06/21/1999 SUPPL-1 Labeling

Label is not available on this site.

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