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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211488

CAMCEVI KIT (LEUPROLIDE MESYLATE)
EQ 42MG BASE
Marketing Status: Prescription
Active Ingredient: LEUPROLIDE MESYLATE
Proprietary Name: CAMCEVI KIT
Dosage Form; Route of Administration: EMULSION; SUBCUTANEOUS
Strength: EQ 42MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211488
Product Number: 001
Approval Date: May 25, 2021
Applicant Holder Full Name: ACCORD BIOPHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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