Details for New Drug Application (NDA): 212038
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NDA 212038 describes ADHANSIA XR, which is a drug marketed by Purdue Pharma Lp and is included in one NDA. There are twelve patents protecting this drug. Additional details are available on the ADHANSIA XR profile page.
The generic ingredient in ADHANSIA XR is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
The generic ingredient in ADHANSIA XR is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 212038
| Tradename: | ADHANSIA XR |
| Applicant: | Purdue Pharma Lp |
| Ingredient: | methylphenidate hydrochloride |
| Patents: | 12 |
| Formulation / Manufacturing: | see details |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 25MG | ||||
| Approval Date: | Feb 27, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 28, 2024 | ||||||||
| Regulatory Exclusivity Use: | LABELING REVISIONS RELATED TO CLINICAL STUDIES | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 30, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 30, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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