General MedicationsORAL-28Standard

DESOGESTREL; ETHINYL ESTRADIOL

Standard Dose

0.125MG/0.025MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview DESOGESTREL; ETHINYL ESTRADIOL is listed in Drugs@FDA under application 077182 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DESOGESTREL; ETHINYL ESTRADIOL Form and strength TABLET; ORAL-28 - 0.125MG/0.025MG Sponsor DR REDDYS LABS SA Submission history Latest submission status date: 2019-10-25 00:00:00.

Structured Monograph

Clinical summary

Approval overview DESOGESTREL; ETHINYL ESTRADIOL is listed in Drugs@FDA under application 077182 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DESOGESTREL; ETHINYL ESTRADIOL Form and strength TABLET; ORAL-28 - 0.125MG/0.025MG Sponsor DR REDDYS LABS SA Submission history Latest submission status date: 2019-10-25 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.