Details for New Drug Application (NDA): 216117
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NDA 216117 describes RELEXXII, which is a drug marketed by Osmotica Pharm Us and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug. Additional details are available on the RELEXXII profile page.
The generic ingredient in RELEXXII is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
The generic ingredient in RELEXXII is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 216117
| Tradename: | RELEXXII |
| Applicant: | Osmotica Pharm Us |
| Ingredient: | methylphenidate hydrochloride |
| Patents: | 5 |
Pharmacology for NDA: 216117
| Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 216117
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RELEXXII | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 216117 | NDA AUTHORIZED GENERIC | Trigen Laboratories, LLC | 13811-700 | 13811-700-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-700-30) |
| RELEXXII | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 216117 | NDA AUTHORIZED GENERIC | Trigen Laboratories, LLC | 13811-711 | 13811-711-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-711-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 18MG | ||||
| Approval Date: | Jun 23, 2022 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Feb 3, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Feb 3, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Feb 3, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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