Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 040891

PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE)
6.25MG/5ML
Marketing Status: Prescription
Active Ingredient: PROMETHAZINE HYDROCHLORIDE
Proprietary Name: PROMETHAZINE HYDROCHLORIDE
Dosage Form; Route of Administration: SYRUP; ORAL
Strength: 6.25MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A040891
Product Number: 001
Approval Date: Mar 13, 2009
Applicant Holder Full Name: NOSTRUM LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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