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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 216606

NISOLDIPINE (NISOLDIPINE)
8.5MG
Marketing Status: Discontinued
Active Ingredient: NISOLDIPINE
Proprietary Name: NISOLDIPINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 8.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A216606
Product Number: 001
Approval Date: Apr 10, 2023
Applicant Holder Full Name: AMTA LABS LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
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