Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 090964

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OXYMORPHONE HYDROCHLORIDE (OXYMORPHONE HYDROCHLORIDE)
5MG
Marketing Status: Prescription

Active Ingredient: OXYMORPHONE HYDROCHLORIDE
Proprietary Name: OXYMORPHONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090964
Product Number: 001
Approval Date: Sep 27, 2010
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

OXYMORPHONE HYDROCHLORIDE (OXYMORPHONE HYDROCHLORIDE)
10MG
Marketing Status: Prescription

Active Ingredient: OXYMORPHONE HYDROCHLORIDE
Proprietary Name: OXYMORPHONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090964
Product Number: 002
Approval Date: Sep 27, 2010
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information