Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214998

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CAMZYOS (MAVACAMTEN)
2.5MG
Marketing Status: Prescription

Active Ingredient: MAVACAMTEN
Proprietary Name: CAMZYOS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 2.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214998
Product Number: 001
Approval Date: Apr 28, 2022
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Prescription
Patent and Exclusivity Information

CAMZYOS (MAVACAMTEN)
5MG
Marketing Status: Prescription

Active Ingredient: MAVACAMTEN
Proprietary Name: CAMZYOS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214998
Product Number: 002
Approval Date: Apr 28, 2022
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Prescription
Patent and Exclusivity Information

CAMZYOS (MAVACAMTEN)
10MG
Marketing Status: Prescription

Active Ingredient: MAVACAMTEN
Proprietary Name: CAMZYOS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214998
Product Number: 003
Approval Date: Apr 28, 2022
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Prescription
Patent and Exclusivity Information

CAMZYOS (MAVACAMTEN)
15MG
Marketing Status: Prescription

Active Ingredient: MAVACAMTEN
Proprietary Name: CAMZYOS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214998
Product Number: 004
Approval Date: Apr 28, 2022
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Prescription
Patent and Exclusivity Information