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General MedicationsORAL-28Generic

DEMULEN 1/35-28

ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE

Standard Dose
0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview DEMULEN 1/35-28 is listed in Drugs@FDA under application 018160 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE Form and strength TABLET;ORAL-28 - 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor GD SEARLE LLC Submission history Latest submission status date: 1999-09-02 00:00:00.

Structured Monograph

Clinical summary

Approval overview DEMULEN 1/35-28 is listed in Drugs@FDA under application 018160 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE Form and strength TABLET;ORAL-28 - 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor GD SEARLE LLC Submission history Latest submission status date: 1999-09-02 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.