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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210612
Company: NOVAST LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET;ORAL Prescription AB No No
ESTRADIOL AND NORETHINDRONE ACETATE 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
04/03/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

ESTRADIOL AND NORETHINDRONE ACETATE

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
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 210612 NOVAST LABS

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
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
ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE 1MG;0.5MG TABLET;ORAL Prescription No AB 210612 NOVAST LABS
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