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General MedicationsORALGeneric

ESTRACE

ESTRADIOL

Standard Dose
0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Marketing status: Discontinued
Summary

Approval overview ESTRACE is listed in Drugs@FDA under application 081295 (ANDA).

Marketing status: Discontinued Active ingredient ESTRADIOL Form and strength TABLET;ORAL - 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor BRISTOL MYERS SQUIBB Submission history Latest submission status date: 2005-09-12 00:00:00.

Structured Monograph

Clinical summary

Approval overview ESTRACE is listed in Drugs@FDA under application 081295 (ANDA). Marketing status: Discontinued Active ingredient ESTRADIOL Form and strength TABLET;ORAL - 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor BRISTOL MYERS SQUIBB Submission history Latest submission status date: 2005-09-12 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued

Interaction Notes

  • No interaction notes stored yet.