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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 202731

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DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE)
25MG
Marketing Status: Prescription
Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202731
Product Number: 001
Approval Date: Jul 5, 2017
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information
DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE)
30MG
Marketing Status: Prescription
Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202731
Product Number: 003
Approval Date: May 19, 2014
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information
DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE)
35MG
Marketing Status: Prescription
Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 35MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202731
Product Number: 004
Approval Date: Jul 5, 2017
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information
DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE)
40MG
Marketing Status: Prescription
Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202731
Product Number: 002
Approval Date: Nov 19, 2013
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information
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