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General MedicationsORALStandard

NORGESTIMATE; ETHINYL ESTRADIOL

NORGESTIMATE; ETHINYL ESTRADIOL

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

Approval overview NORGESTIMATE; ETHINYL ESTRADIOL is listed in Drugs@FDA under application 200494 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient NORGESTIMATE; ETHINYL ESTRADIOL Form and strength TABLET; ORAL - 0.25MG; 0.035MG Sponsor GLENMARK PHARMS LTD Submission history Latest submission status date: 2023-02-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview NORGESTIMATE; ETHINYL ESTRADIOL is listed in Drugs@FDA under application 200494 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient NORGESTIMATE; ETHINYL ESTRADIOL Form and strength TABLET; ORAL - 0.25MG; 0.035MG Sponsor GLENMARK PHARMS LTD Submission history Latest submission status date: 2023-02-22 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.