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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 three suppliers. Additional details are available on the METADATE ER profile page.
The generic ingredient in METADATE ER is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-one 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-two drug master file entries for this compound. Forty-one 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 |
| 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 | Lannett Company, Inc. | 0527-2562 | 0527-2562-37 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-2562-37) |
| METADATE ER | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 089601 | ANDA | Unither Manufacturing, LLC | 53014-594 | 53014-594-07 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (53014-594-07) |
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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