Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 210369
Company: GLENMARK PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET, CHEWABLE;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
12/26/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/29/2018 SUPPL-1 Labeling-Proprietary Name Change

Label is not available on this site.

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

TABLET, CHEWABLE;ORAL; 0.02MG;1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MIBELAS 24 FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET, CHEWABLE;ORAL Prescription No AB 206287 LUPIN ATLANTIS
MINASTRIN 24 FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET, CHEWABLE;ORAL Prescription Yes AB 203667 APIL
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET, CHEWABLE;ORAL Prescription No AB 207514 AMNEAL PHARMS
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET, CHEWABLE;ORAL Prescription No AB 210369 GLENMARK PHARMS LTD
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET, CHEWABLE;ORAL Prescription No AB 209609 XIROMED

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