Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202962
Company: NOVAST LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHABELINA FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG TABLET;ORAL-28 Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/15/2020 ORIG-1 Approval STANDARD

Label is not available on this site.

CHABELINA FE

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
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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