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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091663
Company: XIROMED

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVONORGESTREL AND ETHINYL ESTRADIOL 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
12/21/2012 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
02/06/2023 SUPPL-13 Labeling-Package Insert

Label is not available on this site.
04/29/2022 SUPPL-12 Labeling-Package Insert

Label is not available on this site.
03/04/2022 SUPPL-11 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
03/04/2022 SUPPL-8 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
08/09/2017 SUPPL-7 Labeling-Package Insert

Label is not available on this site.
01/29/2014 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

LEVONORGESTREL AND ETHINYL ESTRADIOL

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 207033 NAARI PTE LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL-28 Prescription No AB 091663 XIROMED
LEVORA 0.15/30-28 ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL-28 Prescription No AB 073594 DR REDDYS LABS SA
MARLISSA ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL-28 Prescription No AB 091452 GLENMARK PHARMS LTD
PORTIA-28 ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL-28 Prescription No AB 075866 BARR
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