DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 204266
» See Plans and Pricing
The generic ingredient in DEXMETHYLPHENIDATE HYDROCHLORIDE is dexmethylphenidate hydrochloride. There are six drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.
Summary for 204266
Tradename: | DEXMETHYLPHENIDATE HYDROCHLORIDE |
Applicant: | Mylan |
Ingredient: | dexmethylphenidate hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 204266
Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for 204266
Suppliers and Packaging for NDA: 204266
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXMETHYLPHENIDATE HYDROCHLORIDE | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 204266 | ANDA | Mylan Pharmaceuticals Inc. | 0378-4080 | 0378-4080-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4080-01) |
DEXMETHYLPHENIDATE HYDROCHLORIDE | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 204266 | ANDA | Mylan Pharmaceuticals Inc. | 0378-4081 | 0378-4081-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4081-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 5MG | ||||
Approval Date: | Aug 25, 2015 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
Approval Date: | Aug 25, 2015 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 15MG | ||||
Approval Date: | Aug 25, 2015 | TE: | AB | RLD: | No |
Complete Access Available with Subscription