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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202317

VALCHLOR (MECHLORETHAMINE HYDROCHLORIDE)
EQ 0.016% BASE
Marketing Status: Prescription
Active Ingredient: MECHLORETHAMINE HYDROCHLORIDE
Proprietary Name: VALCHLOR
Dosage Form; Route of Administration: GEL; TOPICAL
Strength: EQ 0.016% BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N202317
Product Number: 001
Approval Date: Aug 23, 2013
Applicant Holder Full Name: HELSINN BIREX PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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