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FDA Drug Approval, N213977, ONSURA
FDA Drug Approval, N213977, ONSURA
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NDA: 213977
Company: TEVA PHARMS USA
Drug Name: ONSURA
Active Ingredients: ETHINYL ESTRADIOL; NORELGESTROMIN
Strength: 0.035MG/24HR;0.15MG/24HR
Dosage Form/Route: FILM, EXTENDED RELEASE;TRANSDERMAL
Action Date: 08/25/2021
Marketing Status: Prescription
Submission Classification:
Company: TEVA PHARMS USA
Drug Name: ONSURA
Active Ingredients: ETHINYL ESTRADIOL; NORELGESTROMIN
Strength: 0.035MG/24HR;0.15MG/24HR
Dosage Form/Route: FILM, EXTENDED RELEASE;TRANSDERMAL
Action Date: 08/25/2021
Marketing Status: Prescription
Submission Classification:
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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