Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019892

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DILAUDID (HYDROMORPHONE HYDROCHLORIDE)
2MG
Marketing Status: Prescription

Active Ingredient: HYDROMORPHONE HYDROCHLORIDE
Proprietary Name: DILAUDID
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019892
Product Number: 003
Approval Date: Nov 9, 2007
Applicant Holder Full Name: RHODES PHARMACEUTICALS LP
Marketing Status:  Prescription
Patent and Exclusivity Information

DILAUDID (HYDROMORPHONE HYDROCHLORIDE)
4MG
Marketing Status: Prescription

Active Ingredient: HYDROMORPHONE HYDROCHLORIDE
Proprietary Name: DILAUDID
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019892
Product Number: 002
Approval Date: Nov 9, 2007
Applicant Holder Full Name: RHODES PHARMACEUTICALS LP
Marketing Status:  Prescription
Patent and Exclusivity Information

DILAUDID (HYDROMORPHONE HYDROCHLORIDE)
8MG
Marketing Status: Prescription

Active Ingredient: HYDROMORPHONE HYDROCHLORIDE
Proprietary Name: DILAUDID
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 8MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N019892
Product Number: 001
Approval Date: Dec 7, 1992
Applicant Holder Full Name: RHODES PHARMACEUTICALS LP
Marketing Status:  Prescription
Patent and Exclusivity Information