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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203999

DACTINOMYCIN (DACTINOMYCIN)
0.5MG/VIAL
Marketing Status: Prescription
Active Ingredient: DACTINOMYCIN
Proprietary Name: DACTINOMYCIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.5MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A203999
Product Number: 001
Approval Date: May 20, 2019
Applicant Holder Full Name: XGEN PHARMACEUTICALS DJB INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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