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General MedicationsORAL-28Standard

DESOGESTREL AND ETHINYL ESTRADIOL

DESOGESTREL; ETHINYL ESTRADIOL

Standard Dose
0.15MG;0.03MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview DESOGESTREL AND ETHINYL ESTRADIOL is listed in Drugs@FDA under application 219761 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DESOGESTREL; ETHINYL ESTRADIOL Form and strength TABLET;ORAL-28 - 0.15MG;0.03MG Sponsor ANNORA PHARMA Submission history Latest submission status date: 2026-03-18 00:00:00.

Structured Monograph

Clinical summary

Approval overview DESOGESTREL AND ETHINYL ESTRADIOL is listed in Drugs@FDA under application 219761 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DESOGESTREL; ETHINYL ESTRADIOL Form and strength TABLET;ORAL-28 - 0.15MG;0.03MG Sponsor ANNORA PHARMA Submission history Latest submission status date: 2026-03-18 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.