Details for New Drug Application (NDA): 210354
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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-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 210354
Tradename: | METHYLPHENIDATE HYDROCHLORIDE |
Applicant: | Ascent Pharms Inc |
Ingredient: | methylphenidate hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 210354
Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 210354
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | TABLET, CHEWABLE;ORAL | 210354 | ANDA | Camber Pharmaceuticals Inc. | 31722-926 | 31722-926-01 | 100 TABLET, CHEWABLE in 1 BOTTLE (31722-926-01) |
METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | TABLET, CHEWABLE;ORAL | 210354 | ANDA | Camber Pharmaceuticals Inc. | 31722-927 | 31722-927-01 | 100 TABLET, CHEWABLE in 1 BOTTLE (31722-927-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 2.5MG | ||||
Approval Date: | Dec 29, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 5MG | ||||
Approval Date: | Dec 29, 2017 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 10MG | ||||
Approval Date: | Dec 29, 2017 | TE: | AB | RLD: | No |
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