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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019891

DILAUDID (HYDROMORPHONE HYDROCHLORIDE)
5MG/5ML
Marketing Status: Prescription
Active Ingredient: HYDROMORPHONE HYDROCHLORIDE
Proprietary Name: DILAUDID
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 5MG/5ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AA
Application Number: N019891
Product Number: 001
Approval Date: Dec 7, 1992
Applicant Holder Full Name: RHODES PHARMACEUTICALS LP
Marketing Status:  Prescription
Patent and Exclusivity Information
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