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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 217779

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RYTELO (IMETELSTAT SODIUM)
EQ 47MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: IMETELSTAT SODIUM
Proprietary Name: RYTELO
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 47MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N217779
Product Number: 001
Approval Date: Jun 6, 2024
Applicant Holder Full Name: GERON CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
RYTELO (IMETELSTAT SODIUM)
EQ 188MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: IMETELSTAT SODIUM
Proprietary Name: RYTELO
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 188MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N217779
Product Number: 002
Approval Date: Jun 6, 2024
Applicant Holder Full Name: GERON CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
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