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Last Updated: August 14, 2022

Details for New Drug Application (NDA): 205831


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NDA 205831 describes APTENSIO XR, which is a drug marketed by Rhodes Pharms and is included in one NDA. It is available from two suppliers. Additional details are available on the APTENSIO XR profile page.

The generic ingredient in APTENSIO XR 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 205831
Tradename:APTENSIO XR
Applicant:Rhodes Pharms
Ingredient:methylphenidate hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205831
Suppliers and Packaging for NDA: 205831
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831 NDA AUTHORIZED GENERIC Rhodes Pharmaceuticals 42858-075 42858-075-45 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-075-45)
APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831 NDA AUTHORIZED GENERIC Rhodes Pharmaceuticals 42858-076 42858-076-45 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-076-45)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Apr 17, 2015TE:AB3RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength15MG
Approval Date:Apr 17, 2015TE:AB3RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Apr 17, 2015TE:AB3RLD:Yes

Expired US Patents for NDA 205831

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-006 Apr 17, 2015 See Plans and Pricing See Plans and Pricing
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-001 Apr 17, 2015 See Plans and Pricing See Plans and Pricing
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-003 Apr 17, 2015 See Plans and Pricing See Plans and Pricing
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-005 Apr 17, 2015 See Plans and Pricing See Plans and Pricing
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-004 Apr 17, 2015 See Plans and Pricing See Plans and Pricing
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-007 Apr 17, 2015 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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