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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204017

TWIRLA (ETHINYL ESTRADIOL; LEVONORGESTREL)
0.03MG/24HR;0.12MG/24HR
Marketing Status: Prescription
Active Ingredient: ETHINYL ESTRADIOL; LEVONORGESTREL
Proprietary Name: TWIRLA
Dosage Form; Route of Administration: SYSTEM; TRANSDERMAL
Strength: 0.03MG/24HR;0.12MG/24HR
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204017
Product Number: 001
Approval Date: Feb 14, 2020
Applicant Holder Full Name: AGILE THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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