Composition
- Active ingredients
- METHYLPHENIDATE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- METHYLPHENIDATE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Tablet, chewableThis page
- METHYLPHENIDATE HYDROCHLORIDE 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Tablet, chewableNDA021475-001 · Discontinued
- METHYLPHENIDATE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Tablet, chewableNDA021475-002 · Discontinued
- METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML · SolutionNDA021419-001 · Prescription
- METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML · SolutionNDA021419-002 · Prescription
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA021475.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Methylin
- Active substance
- methylphenidate hydrochloride
- Route
- Oral
- Dosage form
- Tablet, chewable
- Applicant
- Specgx LLC
- Status
- Discontinued
- FDA approval
- 15 Apr 2003
- Application
- NDA021475-003