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Last Updated: March 19, 2024

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
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 202880

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Oct 25, 2013TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Jul 25, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Patent:⤷  Try a TrialPatent Expiration:Sep 12, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PAIN
Patent:⤷  Try a TrialPatent Expiration:Jul 25, 2033Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 202880

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

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