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General MedicationsORAL-21Generic

OGESTREL 0.5/50-21

ETHINYL ESTRADIOL; NORGESTREL

Standard Dose
0.05MG;0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 OGESTREL 0.5/50-21 is listed in Drugs@FDA under application 075406 (ANDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient ETHINYL ESTRADIOL; NORGESTREL Form and strength TABLET;ORAL-21 - 0.05MG;0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor WATSON LABS Submission history Latest submission status date: 2022-04-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview OGESTREL 0.5/50-21 is listed in Drugs@FDA under application 075406 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient ETHINYL ESTRADIOL; NORGESTREL Form and strength TABLET;ORAL-21 - 0.05MG;0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor WATSON LABS Submission history Latest submission status date: 2022-04-29 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.
OGESTREL 0.5/50-21 (ETHINYL ESTRADIOL; NORGESTREL) | Drug Monograph | MedicHelpline