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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021419

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METHYLIN (METHYLPHENIDATE HYDROCHLORIDE)
5MG/5ML
Marketing Status: Prescription
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLIN
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 5MG/5ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AA
Application Number: N021419
Product Number: 001
Approval Date: Dec 19, 2002
Applicant Holder Full Name: SPECGX LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
METHYLIN (METHYLPHENIDATE HYDROCHLORIDE)
10MG/5ML
Marketing Status: Prescription
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLIN
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 10MG/5ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AA
Application Number: N021419
Product Number: 002
Approval Date: Dec 19, 2002
Applicant Holder Full Name: SPECGX LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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