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General MedicationsORAL-21Generic

ORTHO-CEPT

DESOGESTREL; ETHINYL ESTRADIOL

Standard Dose
0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 ORTHO-CEPT is listed in Drugs@FDA under application 020301 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient DESOGESTREL; ETHINYL ESTRADIOL Form and strength TABLET;ORAL-21 - 0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor JANSSEN PHARMS Submission history Latest submission status date: 2017-08-09 00:00:00.

Structured Monograph

Clinical summary

Approval overview ORTHO-CEPT is listed in Drugs@FDA under application 020301 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient DESOGESTREL; ETHINYL ESTRADIOL Form and strength TABLET;ORAL-21 - 0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor JANSSEN PHARMS Submission history Latest submission status date: 2017-08-09 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.
ORTHO-CEPT (DESOGESTREL; ETHINYL ESTRADIOL) | Drug Monograph | MedicHelpline