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Details for New Drug Application (NDA): 021419
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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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