Details for New Drug Application (NDA): 215523
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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 215523
Tradename: | DEXMETHYLPHENIDATE HYDROCHLORIDE |
Applicant: | Ascent Pharms Inc |
Ingredient: | dexmethylphenidate hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 215523
Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for 215523
Suppliers and Packaging for NDA: 215523
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXMETHYLPHENIDATE HYDROCHLORIDE | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 215523 | ANDA | Camber Pharmaceuticals, Inc. | 31722-229 | 31722-229-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-229-01) |
DEXMETHYLPHENIDATE HYDROCHLORIDE | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 215523 | ANDA | Camber Pharmaceuticals, Inc. | 31722-230 | 31722-230-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-230-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 5MG | ||||
Approval Date: | Dec 8, 2021 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
Approval Date: | Dec 8, 2021 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 15MG | ||||
Approval Date: | Dec 8, 2021 | TE: | AB | RLD: | No |
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