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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021998

PLAN B ONE-STEP (LEVONORGESTREL)
1.5MG
Marketing Status: Over-the-counter
Active Ingredient: LEVONORGESTREL
Proprietary Name: PLAN B ONE-STEP
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1.5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021998
Product Number: 001
Approval Date: Jul 10, 2009
Applicant Holder Full Name: FOUNDATION CONSUMER HEALTHCARE LLC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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