Details for New Drug Application (NDA): 205489
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NDA 205489 describes COTEMPLA XR-ODT, which is a drug marketed by Neos Theraps Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the COTEMPLA XR-ODT profile page.
The generic ingredient in COTEMPLA XR-ODT is methylphenidate. There are thirty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the methylphenidate profile page.
The generic ingredient in COTEMPLA XR-ODT is methylphenidate. There are thirty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the methylphenidate profile page.
Summary for 205489
| Tradename: | COTEMPLA XR-ODT |
| Applicant: | Neos Theraps Inc |
| Ingredient: | methylphenidate |
| Patents: | 4 |
Pharmacology for NDA: 205489
| Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for 205489
Suppliers and Packaging for NDA: 205489
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COTEMPLA XR-ODT | methylphenidate | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 205489 | NDA | Neos Therapeutics Brands, LLC | 70165-100 | 70165-100-30 | 5 BLISTER PACK in 1 CARTON (70165-100-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
| COTEMPLA XR-ODT | methylphenidate | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 205489 | NDA | Neos Therapeutics Brands, LLC | 70165-200 | 70165-200-30 | 5 BLISTER PACK in 1 CARTON (70165-200-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Strength | 8.6MG | ||||
| Approval Date: | Jun 19, 2017 | TE: | RLD: | Yes | |||||
| Patent: | 11,166,947 | Patent Expiration: | Jan 25, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN PEDIATRIC PATIENTS | ||||||||
| Patent: | 8,840,924 | Patent Expiration: | Jun 5, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 9,072,680 | Patent Expiration: | Jun 28, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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