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-six 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

Pharmacology for NDA: 205831

Physiological Effect	Central Nervous System Stimulation

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:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	10MG
Approval Date:	Apr 17, 2015	TE:	AB3	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	15MG
Approval Date:	Apr 17, 2015	TE:	AB3	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	20MG
Approval Date:	Apr 17, 2015	TE:	AB3	RLD:	Yes

Expired US Patents for NDA 205831

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

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