Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075866
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PORTIA-21 ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL-21 Discontinued None No No
PORTIA-28 ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL-28 Prescription AB 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
05/23/2002 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
08/09/2017 SUPPL-26 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

02/21/2014 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

01/03/2003 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/06/2002 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/06/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/2002 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/2002 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

PORTIA-21

There are no Therapeutic Equivalents.

PORTIA-28

TABLET;ORAL-28; 0.03MG;0.15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALTAVERA ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL-28 Prescription No AB 079102 XIROMED
AYUNA ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL-28 Prescription No AB 206866 AUROBINDO PHARMA LTD
KURVELO ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL-28 Prescription No AB 091408 LUPIN LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL-28 Prescription No AB 201095 AMNEAL PHARMS
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL-28 Prescription No AB 091663 MYLAN LABS LTD
LEVORA 0.15/30-28 ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL-28 Prescription No AB 073594 MAYNE PHARMA
MARLISSA ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL-28 Prescription No AB 091452 GLENMARK GENERICS
PORTIA-28 ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL-28 Prescription No AB 075866 BARR

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