Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203339
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMABELZ ESTRADIOL; NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET;ORAL Prescription AB No No
AMABELZ ESTRADIOL; NORETHINDRONE ACETATE 1MG;0.5MG TABLET;ORAL 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
06/20/2016 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
04/21/2017 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

AMABELZ

TABLET;ORAL; 0.5MG;0.1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTIVELLA ESTRADIOL; NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET;ORAL Prescription Yes AB 020907 AMNEAL PHARMS LLC
AMABELZ ESTRADIOL; NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET;ORAL Prescription No AB 203339 LUPIN LTD
ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET;ORAL Prescription No AB 078324 BRECKENRIDGE PHARM
ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET;ORAL Prescription No AB 207261 MYLAN LABS LTD
ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET;ORAL Prescription No AB 200747 TEVA PHARMS USA

TABLET;ORAL; 1MG;0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTIVELLA ESTRADIOL; NORETHINDRONE ACETATE 1MG;0.5MG TABLET;ORAL Prescription Yes AB 020907 AMNEAL PHARMS LLC
AMABELZ ESTRADIOL; NORETHINDRONE ACETATE 1MG;0.5MG TABLET;ORAL Prescription No AB 203339 LUPIN LTD
ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE 1MG;0.5MG TABLET;ORAL Prescription No AB 079193 BARR
ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE 1MG;0.5MG TABLET;ORAL Prescription No AB 078324 BRECKENRIDGE PHARM
ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE 1MG;0.5MG TABLET;ORAL Prescription No AB 207261 MYLAN LABS LTD

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