Details for New Drug Application (NDA): 075629
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NDA 075629 describes METHYLIN ER, which is a drug marketed by Specgx Llc and is included in one NDA. It is available from one supplier. Additional details are available on the METHYLIN ER profile page.
The generic ingredient in METHYLIN ER 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.
The generic ingredient in METHYLIN ER 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 075629
| Tradename: | METHYLIN ER |
| Applicant: | Specgx Llc |
| Ingredient: | methylphenidate hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075629
| Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 075629
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHYLIN ER | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 075629 | ANDA | SpecGx LLC | 0406-1445 | 0406-1445-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-1445-01) |
| METHYLIN ER | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 075629 | ANDA | SpecGx LLC | 0406-1473 | 0406-1473-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-1473-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
| Approval Date: | May 9, 2000 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 20MG | ||||
| Approval Date: | May 9, 2000 | TE: | AB | RLD: | No | ||||
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