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General MedicationsORAL-28Standard

NORGESTIMATE AND ETHINYL ESTRADIOL

ETHINYL ESTRADIOL; NORGESTIMATE

Standard Dose
0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview NORGESTIMATE AND ETHINYL ESTRADIOL is listed in Drugs@FDA under application 205588 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; NORGESTIMATE Form and strength TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG Sponsor LUPIN LTD Submission history Latest submission status date: 2023-08-23 00:00:00.

Structured Monograph

Clinical summary

Approval overview NORGESTIMATE AND ETHINYL ESTRADIOL is listed in Drugs@FDA under application 205588 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; NORGESTIMATE Form and strength TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG Sponsor LUPIN LTD Submission history Latest submission status date: 2023-08-23 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.