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Details for New Drug Application (NDA): 021419
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NDA 021419 describes METHYLIN, which is a drug marketed by Specgx Llc and is included in three NDAs. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the METHYLIN profile page.
The generic ingredient in METHYLIN is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
The generic ingredient in METHYLIN is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 021419
| Tradename: | METHYLIN |
| Applicant: | Specgx Llc |
| Ingredient: | methylphenidate hydrochloride |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021419
| Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 021419
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHYLIN | methylphenidate hydrochloride | SOLUTION;ORAL | 021419 | NDA AUTHORIZED GENERIC | SpecGx LLC | 0406-3005 | 0406-3005-50 | 500 mL in 1 BOTTLE (0406-3005-50) |
| METHYLIN | methylphenidate hydrochloride | SOLUTION;ORAL | 021419 | NDA AUTHORIZED GENERIC | SpecGx LLC | 0406-3010 | 0406-3010-50 | 500 mL in 1 BOTTLE (0406-3010-50) |
Paragraph IV (Patent) Challenges for 021419
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| METHYLIN | SOLUTION;ORAL | methylphenidate hydrochloride | 021419 | 2010-04-13 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 5MG/5ML | ||||
| Approval Date: | Dec 19, 2002 | TE: | AA | RLD: | Yes | ||||
| Patent: | Start Trial | Patent Expiration: | Oct 7, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 10MG/5ML | ||||
| Approval Date: | Dec 19, 2002 | TE: | AA | RLD: | Yes | ||||
| Patent: | Start Trial | Patent Expiration: | Oct 7, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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