U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075647
Company: MAYNE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MICROGESTIN 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-21 Discontinued None No No
MICROGESTIN FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 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
02/05/2001 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75647ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/31/2021 SUPPL-27 Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

07/30/2003 SUPPL-5 Labeling

Label is not available on this site.

11/07/2002 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

11/18/2002 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

09/04/2001 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Back to Top