Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074425
Company: MYLAN
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
07/08/1997 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
01/21/2016 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

01/21/2016 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

12/12/2005 SUPPL-14 Labeling

Label is not available on this site.

01/12/2007 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

01/21/2004 SUPPL-11 Labeling

Label is not available on this site.

04/19/2000 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

11/15/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/03/1999 SUPPL-8 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/03/1999 SUPPL-7 Labeling

Label is not available on this site.

11/03/1999 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/22/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/25/1998 SUPPL-4 Labeling

Label is not available on this site.

04/07/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/07/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/26/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English