Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 087185
Company: IVAX PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROGENATED ERGOT ALKALOIDS ERGOLOID MESYLATES 1MG TABLET;SUBLINGUAL 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
11/20/1980 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
07/29/2002 SUPPL-32 Manufacturing (CMC)-Facility

Label is not available on this site.

03/12/2002 SUPPL-31 Manufacturing (CMC)-Facility

Label is not available on this site.

06/27/2002 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/21/2000 SUPPL-29 Manufacturing (CMC)-Facility

Label is not available on this site.

07/21/2000 SUPPL-28 Manufacturing (CMC)-Facility

Label is not available on this site.

01/28/2000 SUPPL-27 Manufacturing (CMC)-Facility

Label is not available on this site.

11/23/1999 SUPPL-26 Manufacturing (CMC)-Facility

Label is not available on this site.

08/20/1999 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

11/22/1995 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

08/24/1994 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/27/1995 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/17/1990 SUPPL-18 Labeling

Label is not available on this site.

08/02/1989 SUPPL-17 Labeling

Label is not available on this site.

02/11/1988 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/22/1988 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/11/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/11/1988 SUPPL-13 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