Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 215516

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CISATRACURIUM BESYLATE (CISATRACURIUM BESYLATE)
EQ 2MG BASE/ML
Marketing Status: Prescription

Active Ingredient: CISATRACURIUM BESYLATE
Proprietary Name: CISATRACURIUM BESYLATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2MG BASE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A215516
Product Number: 001
Approval Date: May 24, 2022
Applicant Holder Full Name: GLAND PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

CISATRACURIUM BESYLATE (CISATRACURIUM BESYLATE)
EQ 2MG BASE/ML
Marketing Status: Prescription

Active Ingredient: CISATRACURIUM BESYLATE
Proprietary Name: CISATRACURIUM BESYLATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2MG BASE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A215516
Product Number: 003
Approval Date: Dec 14, 2022
Applicant Holder Full Name: GLAND PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

CISATRACURIUM BESYLATE (CISATRACURIUM BESYLATE)
EQ 10MG BASE/ML
Marketing Status: Prescription

Active Ingredient: CISATRACURIUM BESYLATE
Proprietary Name: CISATRACURIUM BESYLATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 10MG BASE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A215516
Product Number: 002
Approval Date: May 24, 2022
Applicant Holder Full Name: GLAND PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information