Details for New Drug Application (NDA): 211779
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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 211779
Tradename: | METHYLPHENIDATE HYDROCHLORIDE |
Applicant: | Alkem Labs Ltd |
Ingredient: | methylphenidate hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 211779
Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 211779
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | TABLET;ORAL | 211779 | ANDA | Bryant Ranch Prepack | 63629-9471 | 63629-9471-1 | 100 TABLET in 1 BOTTLE (63629-9471-1) |
METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | TABLET;ORAL | 211779 | ANDA | Bryant Ranch Prepack | 63629-9473 | 63629-9473-1 | 100 TABLET in 1 BOTTLE (63629-9473-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Oct 4, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Oct 4, 2019 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Oct 4, 2019 | TE: | AB | RLD: | No |
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