Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203340

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NYMALIZE (NIMODIPINE)
6MG/ML
Marketing Status: Prescription

Active Ingredient: NIMODIPINE
Proprietary Name: NYMALIZE
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 6MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203340
Product Number: 002
Approval Date: Apr 8, 2020
Applicant Holder Full Name: AZURITY PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NYMALIZE (NIMODIPINE)
3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: NIMODIPINE
Proprietary Name: NYMALIZE
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203340
Product Number: 001
Approval Date: May 10, 2013
Applicant Holder Full Name: AZURITY PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information