Details for New Drug Application (NDA): 202880

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NDA 202880 describes ZOHYDRO ER, which is a drug marketed by Recro Gainesville and is included in one NDA. There are sixteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ZOHYDRO ER profile page.

The generic ingredient in ZOHYDRO ER is hydrocodone bitartrate. There are twenty-three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the hydrocodone bitartrate profile page.

Summary for 202880

Tradename:	ZOHYDRO ER
Applicant:	Recro Gainesville
Ingredient:	hydrocodone bitartrate
Patents:	16

Medical Subject Heading (MeSH) Categories for 202880

Analgesics, Opioid
Antitussive Agents
Narcotics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	10MG
Approval Date:	Oct 25, 2013	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jul 25, 2033	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Patent:	⤷ Sign Up	Patent Expiration:	Sep 12, 2034	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PAIN
Patent:	⤷ Sign Up	Patent Expiration:	Jul 25, 2033	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 202880

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-003	Oct 25, 2013	⤷ Sign Up	⤷ Sign Up
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-001	Oct 25, 2013	⤷ Sign Up	⤷ Sign Up
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-006	Oct 25, 2013	⤷ Sign Up	⤷ Sign Up
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-002	Oct 25, 2013	⤷ Sign Up	⤷ Sign Up
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-004	Oct 25, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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