Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213756

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KOSELUGO (SELUMETINIB SULFATE)
EQ 10MG BASE
Marketing Status: Prescription
Active Ingredient: SELUMETINIB SULFATE
Proprietary Name: KOSELUGO
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213756
Product Number: 001
Approval Date: Apr 10, 2020
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status:  Prescription
Patent and Exclusivity Information
KOSELUGO (SELUMETINIB SULFATE)
EQ 25MG BASE
Marketing Status: Prescription
Active Ingredient: SELUMETINIB SULFATE
Proprietary Name: KOSELUGO
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213756
Product Number: 002
Approval Date: Apr 10, 2020
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status:  Prescription
Patent and Exclusivity Information

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