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General MedicationsORAL-21Generic

ORTHO TRI-CYCLEN

ETHINYL ESTRADIOL; NORGESTIMATE

Standard Dose
0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 TRI-CYCLEN is listed in Drugs@FDA under application 019697 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient ETHINYL ESTRADIOL; NORGESTIMATE Form and strength TABLET;ORAL-21 - 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor JANSSEN PHARMS Submission history Latest submission status date: 2023-06-15 00:00:00.

Structured Monograph

Clinical summary

Approval overview ORTHO TRI-CYCLEN is listed in Drugs@FDA under application 019697 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient ETHINYL ESTRADIOL; NORGESTIMATE Form and strength TABLET;ORAL-21 - 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor JANSSEN PHARMS Submission history Latest submission status date: 2023-06-15 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.