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FDA Drug Approval, N214594, ETHINYL ESTRADIOL AND NORELGESTROMIN
FDA Drug Approval, N214594, ETHINYL ESTRADIOL AND NORELGESTROMIN
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NDA: 214594
Company: ZYDUS NOVELTECH INC
Drug Name: ETHINYL ESTRADIOL AND NORELGESTROMIN
Active Ingredients: ETHINYL ESTRADIOL; NORELGESTROMIN
Strength: 0.035MG/24HR;0.15MG/24HR
Dosage Form/Route: FILM, EXTENDED RELEASE;TRANSDERMAL
Action Date: 09/14/2023
Marketing Status: Prescription
Submission Classification:
Company: ZYDUS NOVELTECH INC
Drug Name: ETHINYL ESTRADIOL AND NORELGESTROMIN
Active Ingredients: ETHINYL ESTRADIOL; NORELGESTROMIN
Strength: 0.035MG/24HR;0.15MG/24HR
Dosage Form/Route: FILM, EXTENDED RELEASE;TRANSDERMAL
Action Date: 09/14/2023
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
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