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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212038

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ADHANSIA XR (METHYLPHENIDATE HYDROCHLORIDE)
25MG
Marketing Status: Discontinued
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: ADHANSIA XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212038
Product Number: 001
Approval Date: Feb 27, 2019
Applicant Holder Full Name: PURDUE PHARMA LP
Marketing Status:  Discontinued
Patent and Exclusivity Information
ADHANSIA XR (METHYLPHENIDATE HYDROCHLORIDE)
35MG
Marketing Status: Discontinued
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: ADHANSIA XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 35MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212038
Product Number: 002
Approval Date: Feb 27, 2019
Applicant Holder Full Name: PURDUE PHARMA LP
Marketing Status:  Discontinued
Patent and Exclusivity Information
ADHANSIA XR (METHYLPHENIDATE HYDROCHLORIDE)
45MG
Marketing Status: Discontinued
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: ADHANSIA XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 45MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212038
Product Number: 003
Approval Date: Feb 27, 2019
Applicant Holder Full Name: PURDUE PHARMA LP
Marketing Status:  Discontinued
Patent and Exclusivity Information
ADHANSIA XR (METHYLPHENIDATE HYDROCHLORIDE)
55MG
Marketing Status: Discontinued
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: ADHANSIA XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 55MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212038
Product Number: 004
Approval Date: Feb 27, 2019
Applicant Holder Full Name: PURDUE PHARMA LP
Marketing Status:  Discontinued
Patent and Exclusivity Information
ADHANSIA XR (METHYLPHENIDATE HYDROCHLORIDE)
70MG
Marketing Status: Discontinued
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: ADHANSIA XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 70MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212038
Product Number: 005
Approval Date: Feb 27, 2019
Applicant Holder Full Name: PURDUE PHARMA LP
Marketing Status:  Discontinued
Patent and Exclusivity Information
ADHANSIA XR (METHYLPHENIDATE HYDROCHLORIDE)
85MG
Marketing Status: Discontinued
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: ADHANSIA XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 85MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212038
Product Number: 006
Approval Date: Feb 27, 2019
Applicant Holder Full Name: PURDUE PHARMA LP
Marketing Status:  Discontinued
Patent and Exclusivity Information
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