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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021217

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EXALGO (HYDROMORPHONE HYDROCHLORIDE)
8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: HYDROMORPHONE HYDROCHLORIDE
Proprietary Name: EXALGO
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021217
Product Number: 001
Approval Date: Mar 1, 2010
Applicant Holder Full Name: SPECGX LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
EXALGO (HYDROMORPHONE HYDROCHLORIDE)
12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: HYDROMORPHONE HYDROCHLORIDE
Proprietary Name: EXALGO
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021217
Product Number: 002
Approval Date: Mar 1, 2010
Applicant Holder Full Name: SPECGX LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
EXALGO (HYDROMORPHONE HYDROCHLORIDE)
16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: HYDROMORPHONE HYDROCHLORIDE
Proprietary Name: EXALGO
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021217
Product Number: 003
Approval Date: Mar 1, 2010
Applicant Holder Full Name: SPECGX LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
EXALGO (HYDROMORPHONE HYDROCHLORIDE)
32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: HYDROMORPHONE HYDROCHLORIDE
Proprietary Name: EXALGO
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021217
Product Number: 004
Approval Date: Aug 24, 2012
Applicant Holder Full Name: SPECGX LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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