Details for New Drug Application (NDA): 208737
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The generic ingredient in METHYLPHENIDATE HYDROCHLORIDE is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 208737
Tradename: | METHYLPHENIDATE HYDROCHLORIDE |
Applicant: | Cediprof Inc |
Ingredient: | methylphenidate hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208737
Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 208737
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | TABLET;ORAL | 208737 | ANDA | Neolpharma, Inc. | 55466-101 | 55466-101-12 | 100 TABLET in 1 BOTTLE (55466-101-12) |
METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | TABLET;ORAL | 208737 | ANDA | Neolpharma, Inc. | 55466-102 | 55466-102-12 | 100 TABLET in 1 BOTTLE (55466-102-12) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Feb 1, 2019 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Feb 1, 2019 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Feb 1, 2019 | TE: | RLD: | No |
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