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General MedicationsORALGeneric

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Standard Dose
0.0025MG;0.5MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL is listed in Drugs@FDA under application 207260 (ANDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient ETHINYL ESTRADIOL; NORETHINDRONE ACETATE Form and strength TABLET;ORAL - 0.0025MG;0.5MG Sponsor XIROMED Submission history Latest submission status date: 2024-02-16 00:00:00.

Structured Monograph

Clinical summary

Approval overview NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL is listed in Drugs@FDA under application 207260 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient ETHINYL ESTRADIOL; NORETHINDRONE ACETATE Form and strength TABLET;ORAL - 0.0025MG;0.5MG Sponsor XIROMED Submission history Latest submission status date: 2024-02-16 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.