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Details for New Drug Application (NDA): 089601
NDA 089601 describes METADATE ER, which is a drug marketed by Lannett Co Inc and is included in two NDAs. It is available from two suppliers. Additional details are available on the METADATE ER profile page.
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.
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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