Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 080172
Company: ACTAVIS ELIZABETH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPYLTHIOURACIL PROPYLTHIOURACIL 50MG TABLET;ORAL Prescription BD 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
01/09/1973 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
10/13/2011 SUPPL-50 REMS-Modified

Label is not available on this site.

10/11/2011 SUPPL-49 Labeling-Package Insert

Label is not available on this site.

01/21/2011 SUPPL-48 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert, REMS-Proposal

Label is not available on this site.

12/15/2010 SUPPL-46 REMS-Proposal

Label is not available on this site.

03/25/2002 SUPPL-33 Labeling

Label is not available on this site.

11/02/2001 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

12/11/2000 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

10/29/1999 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

01/18/1996 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

04/07/1994 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

04/07/1994 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/23/1991 SUPPL-25 Labeling

Label is not available on this site.

05/23/1988 SUPPL-24 Labeling

Label is not available on this site.

07/21/1988 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

07/16/1987 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/23/1987 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

02/20/1985 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/20/1985 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/26/1983 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/26/1983 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

PROPYLTHIOURACIL

There are no Therapeutic Equivalents.

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