Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 080154
Company: HIKMA INTL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPYLTHIOURACIL PROPYLTHIOURACIL 50MG TABLET;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
07/23/1971 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
11/30/2016 SUPPL-42 Labeling-Package Insert

Label is not available on this site.

11/30/2016 SUPPL-39 Labeling-Container/Carton Labels

Label is not available on this site.

08/22/2011 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

12/29/2010 SUPPL-36 Labeling-Package Insert, REMS-Proposal

Label is not available on this site.

11/21/2002 SUPPL-32 Labeling

Label is not available on this site.

03/12/2002 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/2001 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

03/12/2001 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1998 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

02/17/1999 SUPPL-26 Labeling

Label is not available on this site.

02/17/1999 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/31/1995 SUPPL-22 Labeling

Label is not available on this site.

01/31/1995 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/31/1995 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

01/31/1995 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

01/31/1995 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/19/1985 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/19/1984 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/26/1983 SUPPL-7 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