Details for New Drug Application (NDA): 213813
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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 213813
Tradename: | DEXMETHYLPHENIDATE HYDROCHLORIDE |
Applicant: | Granules |
Ingredient: | dexmethylphenidate hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 213813
Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for 213813
Suppliers and Packaging for NDA: 213813
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXMETHYLPHENIDATE HYDROCHLORIDE | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 213813 | ANDA | Granules Pharmaceuticals Inc. | 70010-004 | 70010-004-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-004-01) |
DEXMETHYLPHENIDATE HYDROCHLORIDE | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 213813 | ANDA | Granules Pharmaceuticals Inc. | 70010-005 | 70010-005-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-005-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 5MG | ||||
Approval Date: | Sep 9, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
Approval Date: | Sep 9, 2020 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 15MG | ||||
Approval Date: | Sep 9, 2020 | TE: | AB | RLD: | No |
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