Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021876

DICLEGIS (DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE)
10MG;10MG Marketing Status: Prescription

Active Ingredient: DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Proprietary Name: DICLEGIS
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 10MG;10MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021876
Product Number: 001
Approval Date: Apr 8, 2013
Applicant Holder Full Name: DUCHESNAY INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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