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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204278

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HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
8MG
Marketing Status: Prescription
Active Ingredient: HYDROMORPHONE HYDROCHLORIDE
Proprietary Name: HYDROMORPHONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 8MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204278
Product Number: 001
Approval Date: Apr 6, 2015
Applicant Holder Full Name: PADAGIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
12MG
Marketing Status: Prescription
Active Ingredient: HYDROMORPHONE HYDROCHLORIDE
Proprietary Name: HYDROMORPHONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 12MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204278
Product Number: 002
Approval Date: Apr 6, 2015
Applicant Holder Full Name: PADAGIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
16MG
Marketing Status: Prescription
Active Ingredient: HYDROMORPHONE HYDROCHLORIDE
Proprietary Name: HYDROMORPHONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 16MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204278
Product Number: 003
Approval Date: Apr 6, 2015
Applicant Holder Full Name: PADAGIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
32MG
Marketing Status: Prescription
Active Ingredient: HYDROMORPHONE HYDROCHLORIDE
Proprietary Name: HYDROMORPHONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 32MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204278
Product Number: 004
Approval Date: Sep 20, 2017
Applicant Holder Full Name: PADAGIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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