Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214292
Company: AMNEAL PHARMS
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 CAPSULE;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
07/20/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214292Orig1s000TA_ltr.pdf

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

CAPSULE;ORAL; 0.02MG;1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GEMMILY ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG CAPSULE;ORAL Prescription No AB 213317 XIROMED
MERZEE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG CAPSULE;ORAL Prescription No AB 212706 SLAYBACK PHARMA LLC
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG CAPSULE;ORAL Prescription No AB 214292 AMNEAL PHARMS
TAYTULLA ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG CAPSULE;ORAL Prescription Yes AB 204426 APIL

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