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.
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
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: | 10,028,946 | Patent Expiration: | Jul 25, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT | ||||||||
| Patent: | 10,092,559 | Patent Expiration: | Sep 12, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PAIN | ||||||||
| Patent: | 10,322,120 | Patent Expiration: | Jul 25, 2033 | Product Flag? | Y | Substance 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 | 6,228,398 | ⤷ Subscribe |
| Recro Gainesville | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-002 | Oct 25, 2013 | 6,902,742 | ⤷ Subscribe |
| Recro Gainesville | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-001 | Oct 25, 2013 | 6,228,398 | ⤷ Subscribe |
| Recro Gainesville | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-003 | Oct 25, 2013 | 6,228,398 | ⤷ Subscribe |
| Recro Gainesville | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-004 | Oct 25, 2013 | 6,902,742 | ⤷ Subscribe |
| Recro Gainesville | ZOHYDRO ER | hydrocodone bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880-003 | Oct 25, 2013 | 6,902,742 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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