Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 086557
Company: COSETTE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MIGERGOT CAFFEINE; ERGOTAMINE TARTRATE 100MG;2MG SUPPOSITORY;RECTAL Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/04/1983 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
11/08/2012 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

06/18/2012 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

08/01/2003 SUPPL-12 Labeling

Label is not available on this site.

10/19/1999 SUPPL-6 Labeling

Label is not available on this site.

03/12/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/12/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/12/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/20/1987 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