Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 074597

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HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
4MG
Marketing Status: Discontinued

Active Ingredient: HYDROMORPHONE HYDROCHLORIDE
Proprietary Name: HYDROMORPHONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A074597
Product Number: 003
Approval Date: May 29, 2009
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
8MG
Marketing Status: Discontinued

Active Ingredient: HYDROMORPHONE HYDROCHLORIDE
Proprietary Name: HYDROMORPHONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 8MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A074597
Product Number: 001
Approval Date: Jul 29, 1998
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information