Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074878
Company: ANI PHARMS INC
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
07/09/1997 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/02/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

03/30/2001 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/2000 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/2000 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

02/16/2000 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

02/16/2000 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/28/2000 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/21/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/06/1998 SUPPL-2 Labeling

Label is not available on this site.

03/02/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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