Details for New Drug Application (NDA): 078873
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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 078873
Tradename: | METHYLPHENIDATE HYDROCHLORIDE |
Applicant: | Teva Pharms |
Ingredient: | methylphenidate hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078873
Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 078873
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 078873 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-5292 | 0093-5292-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5292-01) |
METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 078873 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-5293 | 0093-5293-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5293-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 40MG | ||||
Approval Date: | Jul 19, 2012 | TE: | AB2 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 50MG | ||||
Approval Date: | Jul 19, 2012 | TE: | AB2 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 60MG | ||||
Approval Date: | Jul 19, 2012 | TE: | AB2 | RLD: | No |
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