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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 021693

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NDA 021693 describes RYBIX ODT, which is a drug marketed by Shionogi Inc and is included in one NDA. Additional details are available on the RYBIX ODT profile page.

The generic ingredient in RYBIX ODT is tramadol hydrochloride. There are thirty-six drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.

Summary for 021693

Tradename:	RYBIX ODT
Applicant:	Shionogi Inc
Ingredient:	tramadol hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 021693

Analgesics, Opioid
Narcotics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	50MG
Approval Date:	May 5, 2005	TE:		RLD:	No

Expired US Patents for NDA 021693

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Shionogi Inc	RYBIX ODT	tramadol hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021693-001	May 5, 2005	5,464,632	⤷ Get Started Free
Shionogi Inc	RYBIX ODT	tramadol hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021693-001	May 5, 2005	6,106,861	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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