Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078892
Company: AMNEAL PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG 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
09/26/2011 ORIG-1 Approval

Label is not available on this site.

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

TABLET, CHEWABLE;ORAL; 0.035MG;0.4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NEXESTA FE ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET, CHEWABLE;ORAL Prescription No AB 207535 AUROBINDO PHARMA LTD
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET, CHEWABLE;ORAL Prescription No AB 207066 ACCORD HLTHCARE
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET, CHEWABLE;ORAL Prescription No AB 078892 AMNEAL PHARMS
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET, CHEWABLE;ORAL Prescription No AB 078965 BARR
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET, CHEWABLE;ORAL Prescription No AB 091332 LUPIN LTD
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET, CHEWABLE;ORAL Prescription No AB 202086 MYLAN LABS LTD

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