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General MedicationsORAL-28Standard

HAILEY FE 1.5/30

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Standard Dose
0.03MG;1.5MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview HAILEY FE 1.5/30 is listed in Drugs@FDA under application 209031 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; NORETHINDRONE ACETATE Form and strength TABLET;ORAL-28 - 0.03MG;1.5MG Sponsor GLENMARK SPECLT Submission history Latest submission status date: 2023-07-14 00:00:00.

Structured Monograph

Clinical summary

Approval overview HAILEY FE 1.5/30 is listed in Drugs@FDA under application 209031 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; NORETHINDRONE ACETATE Form and strength TABLET;ORAL-28 - 0.03MG;1.5MG Sponsor GLENMARK SPECLT Submission history Latest submission status date: 2023-07-14 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.