Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205858

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ZYDELIG (IDELALISIB)
100MG
Marketing Status: Prescription

Active Ingredient: IDELALISIB
Proprietary Name: ZYDELIG
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205858
Product Number: 001
Approval Date: Jul 23, 2014
Applicant Holder Full Name: GILEAD SCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ZYDELIG (IDELALISIB)
150MG
Marketing Status: Prescription

Active Ingredient: IDELALISIB
Proprietary Name: ZYDELIG
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205858
Product Number: 002
Approval Date: Jul 23, 2014
Applicant Holder Full Name: GILEAD SCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information