Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075803
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LESSINA-21 ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET;ORAL-21 Discontinued None No No
LESSINA-28 ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET;ORAL-28 Prescription AB2 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
03/20/2002 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/75803_Levonorgestrel And Ethinyl Estradiol_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75803.ap.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/075803_levonorgestrel-ethinyl_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2017 SUPPL-29 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

11/27/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/2002 SUPPL-2 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/30/2002 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/20/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/75803_Levonorgestrel And Ethinyl Estradiol_Prntlbl.pdf

LESSINA-21

There are no Therapeutic Equivalents.

LESSINA-28

TABLET;ORAL-28; 0.02MG;0.1MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LESSINA-28 ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET;ORAL-28 Prescription No AB2 075803 BARR
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET;ORAL-28 Prescription No AB2 077681 MAYNE PHARMA
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET;ORAL-28 Prescription No AB2 202247 MYLAN LABS LTD

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