Details for New Drug Application (NDA): 212631
✉ Email this page to a colleague
The generic ingredient in DEXMETHYLPHENIDATE HYDROCHLORIDE is dexmethylphenidate hydrochloride. There are six drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.
Summary for 212631
Tradename: | DEXMETHYLPHENIDATE HYDROCHLORIDE |
Applicant: | Alkem Labs Ltd |
Ingredient: | dexmethylphenidate hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 212631
Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for 212631
Suppliers and Packaging for NDA: 212631
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXMETHYLPHENIDATE HYDROCHLORIDE | dexmethylphenidate hydrochloride | TABLET;ORAL | 212631 | ANDA | Bryant Ranch Prepack | 63629-9467 | 63629-9467-1 | 100 TABLET in 1 BOTTLE (63629-9467-1) |
DEXMETHYLPHENIDATE HYDROCHLORIDE | dexmethylphenidate hydrochloride | TABLET;ORAL | 212631 | ANDA | Bryant Ranch Prepack | 63629-9468 | 63629-9468-1 | 100 TABLET in 1 BOTTLE (63629-9468-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | Jul 19, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Jul 19, 2019 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Jul 19, 2019 | TE: | AB | RLD: | No |
Complete Access Available with Subscription