Details for New Drug Application (NDA): 211796
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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 211796
Tradename: | METHYLPHENIDATE HYDROCHLORIDE |
Applicant: | Granules |
Ingredient: | methylphenidate hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 211796
Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 211796
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 211796 | ANDA | Granules Pharmaceuticals Inc. | 70010-012 | 70010-012-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-012-01) |
METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 211796 | ANDA | Granules Pharmaceuticals Inc. | 70010-013 | 70010-013-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-013-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
Approval Date: | May 23, 2019 | TE: | AB1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 20MG | ||||
Approval Date: | May 23, 2019 | TE: | AB1 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 30MG | ||||
Approval Date: | May 23, 2019 | TE: | AB1 | RLD: | No |
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