Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 207518

AZACITIDINE (AZACITIDINE)
100MG/VIAL Marketing Status: Prescription

Active Ingredient: AZACITIDINE
Proprietary Name: AZACITIDINE
Dosage Form; Route of Administration: POWDER; INTRAVENOUS, SUBCUTANEOUS
Strength: 100MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A207518
Product Number: 001
Approval Date: Sep 29, 2016
Applicant Holder Full Name: SHILPA MEDICARE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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