Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076629
Company: MAYNE PHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG 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
03/18/2010 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/076629s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/13/2015 SUPPL-5 Labeling

Label is not available on this site.

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

TABLET;ORAL-28; 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHABELINA FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG TABLET;ORAL-28 Prescription No AB 202962 NOVAST LABS
ESTROSTEP FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG TABLET;ORAL-28 Prescription Yes AB 020130 APIL
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG TABLET;ORAL-28 Prescription No AB 076629 MAYNE PHARMA
TRI-LEGEST FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG TABLET;ORAL-28 Prescription No AB 076105 BARR

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