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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091408
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KURVELO 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
10/17/2012 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
04/29/2022 SUPPL-14 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

03/01/2022 SUPPL-13 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

03/02/2020 SUPPL-10 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

03/02/2020 SUPPL-9 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

03/02/2020 SUPPL-7 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

08/09/2017 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

01/28/2014 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

KURVELO

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
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
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL-28 Prescription No AB 207033 NAARI PTE 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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