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Details for New Drug Application (NDA): 089601
The generic ingredient in METADATE ER is methylphenidate hydrochloride. There are thirty-one drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 089601
Tradename: | METADATE ER |
Applicant: | Lannett Co Inc |
Ingredient: | methylphenidate hydrochloride |
Patents: | 0 |
Therapeutic Class: | Central Nervous System Agents |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 089601
Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 089601
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METADATE ER | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 089601 | ANDA | Unither Manufacturing, LLC | 53014-594 | E | 53014-594-07 |
METADATE ER | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 089601 | ANDA | Upstate Pharma, LLC | 65580-594 | N | 65580-594-01 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 20MG | ||||
Approval Date: | Jun 1, 1988 | TE: | AB | RLD: | No |
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