Details for New Drug Application (NDA): 206931
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The generic ingredient in DEXMETHYLPHENIDATE HYDROCHLORIDE is dexmethylphenidate hydrochloride. There are six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.
Summary for 206931
Tradename: | DEXMETHYLPHENIDATE HYDROCHLORIDE |
Applicant: | Abhai Inc |
Ingredient: | dexmethylphenidate hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 206931
Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for 206931
Suppliers and Packaging for NDA: 206931
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXMETHYLPHENIDATE HYDROCHLORIDE | dexmethylphenidate hydrochloride | TABLET;ORAL | 206931 | ANDA | KVK-TECH, INC | 10702-106 | 10702-106-01 | 100 TABLET in 1 BOTTLE (10702-106-01) |
DEXMETHYLPHENIDATE HYDROCHLORIDE | dexmethylphenidate hydrochloride | TABLET;ORAL | 206931 | ANDA | KVK-TECH, INC | 10702-107 | 10702-107-01 | 100 TABLET in 1 BOTTLE (10702-107-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | Dec 4, 2015 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Dec 4, 2015 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Dec 4, 2015 | TE: | AB | RLD: | No |
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