Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205831

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APTENSIO XR (METHYLPHENIDATE HYDROCHLORIDE)
10MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: APTENSIO XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB3
Application Number: N205831
Product Number: 001
Approval Date: Apr 17, 2015
Applicant Holder Full Name: RHODES PHARMACEUTICALS LP
Marketing Status:  Prescription
Patent and Exclusivity Information

APTENSIO XR (METHYLPHENIDATE HYDROCHLORIDE)
15MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: APTENSIO XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB3
Application Number: N205831
Product Number: 002
Approval Date: Apr 17, 2015
Applicant Holder Full Name: RHODES PHARMACEUTICALS LP
Marketing Status:  Prescription
Patent and Exclusivity Information

APTENSIO XR (METHYLPHENIDATE HYDROCHLORIDE)
20MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: APTENSIO XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB3
Application Number: N205831
Product Number: 003
Approval Date: Apr 17, 2015
Applicant Holder Full Name: RHODES PHARMACEUTICALS LP
Marketing Status:  Prescription
Patent and Exclusivity Information

APTENSIO XR (METHYLPHENIDATE HYDROCHLORIDE)
30MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: APTENSIO XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB3
Application Number: N205831
Product Number: 004
Approval Date: Apr 17, 2015
Applicant Holder Full Name: RHODES PHARMACEUTICALS LP
Marketing Status:  Prescription
Patent and Exclusivity Information

APTENSIO XR (METHYLPHENIDATE HYDROCHLORIDE)
40MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: APTENSIO XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB3
Application Number: N205831
Product Number: 005
Approval Date: Apr 17, 2015
Applicant Holder Full Name: RHODES PHARMACEUTICALS LP
Marketing Status:  Prescription
Patent and Exclusivity Information

APTENSIO XR (METHYLPHENIDATE HYDROCHLORIDE)
50MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: APTENSIO XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB3
Application Number: N205831
Product Number: 006
Approval Date: Apr 17, 2015
Applicant Holder Full Name: RHODES PHARMACEUTICALS LP
Marketing Status:  Prescription
Patent and Exclusivity Information

APTENSIO XR (METHYLPHENIDATE HYDROCHLORIDE)
60MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: APTENSIO XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 60MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB3
Application Number: N205831
Product Number: 007
Approval Date: Apr 17, 2015
Applicant Holder Full Name: RHODES PHARMACEUTICALS LP
Marketing Status:  Prescription
Patent and Exclusivity Information