Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 215592

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NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE (NICARDIPINE HYDROCHLORIDE)
20MG/200ML (0.1MG/ML)
Marketing Status: Prescription

Active Ingredient: NICARDIPINE HYDROCHLORIDE
Proprietary Name: NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 20MG/200ML (0.1MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A215592
Product Number: 001
Approval Date: Sep 24, 2024
Applicant Holder Full Name: CIPLA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE (NICARDIPINE HYDROCHLORIDE)
40MG/200ML (0.2MG/ML)
Marketing Status: Prescription

Active Ingredient: NICARDIPINE HYDROCHLORIDE
Proprietary Name: NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 40MG/200ML (0.2MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A215592
Product Number: 002
Approval Date: Sep 24, 2024
Applicant Holder Full Name: CIPLA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information