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General MedicationsORAL-28Standard

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Standard Dose
0.02MG,0.03MG,0.035MG;1MG,1MG,1MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL is listed in Drugs@FDA under application 205069 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; NORETHINDRONE ACETATE Form and strength TABLET;ORAL-28 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Sponsor XIROMED Submission history Latest submission status date: 2022-04-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL is listed in Drugs@FDA under application 205069 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; NORETHINDRONE ACETATE Form and strength TABLET;ORAL-28 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Sponsor XIROMED Submission history Latest submission status date: 2022-04-29 00:00:00. Submission type: SUPPL.

Monitoring

  • Marketing status: Prescription
  • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.