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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019034

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DILAUDID (HYDROMORPHONE HYDROCHLORIDE)
0.2MG/ML
Marketing Status: Prescription
Active Ingredient: HYDROMORPHONE HYDROCHLORIDE
Proprietary Name: DILAUDID
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.2MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N019034
Product Number: 006
Approval Date: Jan 16, 2020
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
DILAUDID (HYDROMORPHONE HYDROCHLORIDE)
0.5MG/0.5ML
Marketing Status: Prescription
Active Ingredient: HYDROMORPHONE HYDROCHLORIDE
Proprietary Name: DILAUDID
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.5MG/0.5ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N019034
Product Number: 007
Approval Date: Feb 10, 2017
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
DILAUDID (HYDROMORPHONE HYDROCHLORIDE)
1MG/ML
Marketing Status: Prescription
Active Ingredient: HYDROMORPHONE HYDROCHLORIDE
Proprietary Name: DILAUDID
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N019034
Product Number: 003
Approval Date: Apr 30, 2009
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
DILAUDID (HYDROMORPHONE HYDROCHLORIDE)
2MG/ML
Marketing Status: Prescription
Active Ingredient: HYDROMORPHONE HYDROCHLORIDE
Proprietary Name: DILAUDID
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N019034
Product Number: 004
Approval Date: Apr 30, 2009
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
DILAUDID (HYDROMORPHONE HYDROCHLORIDE)
4MG/ML
Marketing Status: Discontinued
Active Ingredient: HYDROMORPHONE HYDROCHLORIDE
Proprietary Name: DILAUDID
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 4MG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019034
Product Number: 005
Approval Date: Apr 30, 2009
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
DILAUDID-HP (HYDROMORPHONE HYDROCHLORIDE)
10MG/ML
Marketing Status: Discontinued
Active Ingredient: HYDROMORPHONE HYDROCHLORIDE
Proprietary Name: DILAUDID-HP
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019034
Product Number: 001
Approval Date: Jan 11, 1984
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
DILAUDID-HP (HYDROMORPHONE HYDROCHLORIDE)
250MG/VIAL
Marketing Status: Discontinued
Active Ingredient: HYDROMORPHONE HYDROCHLORIDE
Proprietary Name: DILAUDID-HP
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 250MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019034
Product Number: 002
Approval Date: Aug 4, 1994
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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