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General MedicationsTRANSDERMALStandard

ETHINYL ESTRADIOL AND NORELGESTROMIN

ETHINYL ESTRADIOL; NORELGESTROMIN

Standard Dose
0.035MG/24HR;0.15MG/24HR
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview ETHINYL ESTRADIOL AND NORELGESTROMIN is listed in Drugs@FDA under application 214594 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; NORELGESTROMIN Form and strength FILM, EXTENDED RELEASE;TRANSDERMAL - 0.035MG/24HR;0.15MG/24HR Sponsor ZYDUS PHARMS Submission history Latest submission status date: 2023-09-14 00:00:00.

Structured Monograph

Clinical summary

Approval overview ETHINYL ESTRADIOL AND NORELGESTROMIN is listed in Drugs@FDA under application 214594 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; NORELGESTROMIN Form and strength FILM, EXTENDED RELEASE;TRANSDERMAL - 0.035MG/24HR;0.15MG/24HR Sponsor ZYDUS PHARMS Submission history Latest submission status date: 2023-09-14 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.