Details for New Drug Application (NDA): 205489
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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: | ⤷ Sign Up | Patent Expiration: | Jan 25, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN PEDIATRIC PATIENTS | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 5, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 28, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? |
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