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): 201510
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PIRMELLA 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,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
04/24/2013 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/29/2022 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

04/29/2019 SUPPL-11 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

03/22/2019 SUPPL-8 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

08/22/2016 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

04/13/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

Back to Top