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BEKYREE از شرکت LUPIN LTD

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BEKYREE از شرکت LUPIN LTD

Abbreviated New Drug Application (ANDA): 202226

Company: LUPIN LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BEKYREE DESOGESTREL; ETHINYL ESTRADIOL 0.15MG,N/A;0.02MG,0.01MG 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
08/12/2015 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
03/30/2020 SUPPL-7 Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

03/30/2020 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/09/2017 SUPPL-3 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

BEKYREE

TABLET;ORAL-28; 0.15MG,N/A;0.02MG,0.01MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BEKYREE DESOGESTREL; ETHINYL ESTRADIOL 0.15MG,N/A;0.02MG,0.01MG TABLET;ORAL-28 Prescription No AB 202226 LUPIN LTD
DESOGESTREL AND ETHINYL ESTRADIOL DESOGESTREL; ETHINYL ESTRADIOL 0.15MG,N/A;0.02MG,0.01MG TABLET;ORAL-28 Prescription No AB 076916 MAYNE PHARMA
DESOGESTREL AND ETHINYL ESTRADIOL DESOGESTREL; ETHINYL ESTRADIOL 0.15MG,N/A;0.02MG,0.01MG TABLET;ORAL-28 Prescription No AB 202296 MYLAN LABS LTD
DESOGESTREL AND ETHINYL ESTRADIOL DESOGESTREL; ETHINYL ESTRADIOL 0.15MG,N/A;0.02MG,0.01MG TABLET;ORAL-28 Prescription No AB 209170 NAARI PTE LTD
KARIVA DESOGESTREL; ETHINYL ESTRADIOL 0.15MG,N/A;0.02MG,0.01MG TABLET;ORAL-28 Prescription No AB 075863 BARR
KIMIDESS DESOGESTREL; ETHINYL ESTRADIOL 0.15MG,N/A;0.02MG,0.01MG TABLET;ORAL-28 Prescription No AB 076681 VINTAGE PHARMS
PIMTREA DESOGESTREL; ETHINYL ESTRADIOL 0.15MG,N/A;0.02MG,0.01MG TABLET;ORAL-28 Prescription No AB 091247 NOVAST LABS
SIMLIYA DESOGESTREL; ETHINYL ESTRADIOL 0.15MG,N/A;0.02MG,0.01MG TABLET;ORAL-28 Prescription No AB 206853 AUROBINDO PHARMA LTD
VIORELE DESOGESTREL; ETHINYL ESTRADIOL 0.15MG,N/A;0.02MG,0.01MG TABLET;ORAL-28 Prescription No AB 091346 GLENMARK GENERICS
VOLNEA DESOGESTREL; ETHINYL ESTRADIOL 0.15MG,N/A;0.02MG,0.01MG TABLET;ORAL-28 Prescription No AB 202689 XIROMED
حتما بخوانید : CALDEROL از شرکت ORGANON USA INC
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