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General MedicationsORAL-28Standard

MALMOREDE

ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE

Standard Dose
0.05MG;1MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview MALMOREDE is listed in Drugs@FDA under application 209547 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE Form and strength TABLET;ORAL-28 - 0.05MG;1MG Sponsor NOVAST LABS Submission history Latest submission status date: 2018-07-25 00:00:00.

Structured Monograph

Clinical summary

Approval overview MALMOREDE is listed in Drugs@FDA under application 209547 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE Form and strength TABLET;ORAL-28 - 0.05MG;1MG Sponsor NOVAST LABS Submission history Latest submission status date: 2018-07-25 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.