Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022549

10MG Marketing Status: Prescription

Active Ingredient: LOXAPINE
Proprietary Name: ADASUVE
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022549
Product Number: 001
Approval Date: Dec 21, 2012
Applicant Holder Full Name: GALEN LTD
Marketing Status:  Prescription
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