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Drugs@FDA: FDA-Approved Drugs

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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 BX No No
AMABELZ ESTRADIOL; NORETHINDRONE ACETATE 1MG;0.5MG TABLET;ORAL Prescription BX 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

There are no Therapeutic Equivalents.

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