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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203585

SYNRIBO (OMACETAXINE MEPESUCCINATE)
3.5MG/VIAL
Marketing Status: Prescription
Active Ingredient: OMACETAXINE MEPESUCCINATE
Proprietary Name: SYNRIBO
Dosage Form; Route of Administration: POWDER; SUBCUTANEOUS
Strength: 3.5MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203585
Product Number: 001
Approval Date: Oct 26, 2012
Applicant Holder Full Name: TEVA PHARMACEUTICALS INTERNATIONAL GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information
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