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General MedicationsORAL-28Standard

LO-MALMOREDE

ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE

Standard Dose
0.035MG;1MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview LO-MALMOREDE is listed in Drugs@FDA under application 209548 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE Form and strength TABLET;ORAL-28 - 0.035MG;1MG Sponsor NOVAST LABS Submission history Latest submission status date: 2019-02-11 00:00:00.

Structured Monograph

Clinical summary

Approval overview LO-MALMOREDE is listed in Drugs@FDA under application 209548 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE Form and strength TABLET;ORAL-28 - 0.035MG;1MG Sponsor NOVAST LABS Submission history Latest submission status date: 2019-02-11 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.
LO-MALMOREDE (ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE) | Drug Monograph | MedicHelpline