Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202880
Company: RECRO GAINESVILLE
Company: RECRO GAINESVILLE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZOHYDRO ER | HYDROCODONE BITARTRATE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
ZOHYDRO ER | HYDROCODONE BITARTRATE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
ZOHYDRO ER | HYDROCODONE BITARTRATE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
ZOHYDRO ER | HYDROCODONE BITARTRATE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
ZOHYDRO ER | HYDROCODONE BITARTRATE | 40MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
ZOHYDRO ER | HYDROCODONE BITARTRATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/25/2013 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202880s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202880Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202880Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202880Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/04/2021 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202880s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202880Orig1s020ltr.pdf | |
10/07/2019 | SUPPL-19 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202880s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202880Orig1s019ltr.pdf | |
09/18/2018 | SUPPL-15 | REMS, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202880s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202880Orig1s014s015ltr.pdf | |
09/18/2018 | SUPPL-14 | REMS - MODIFIED - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202880s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202880Orig1s014s015ltr.pdf | |
05/26/2017 | SUPPL-12 | REMS-Proposal |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202880Orig1s012ltr.pdf |
09/30/2016 | SUPPL-11 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202880Orig1s011ltr.pdf |
12/16/2016 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202880s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202880Orig1s009,s010ltr.pdf | |
12/16/2016 | SUPPL-9 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202880s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202880Orig1s009,s010ltr.pdf | |
04/20/2016 | SUPPL-7 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202880Orig1s007ltr.pdf |
06/26/2015 | SUPPL-6 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202880Orig1s006ltr.pdf |
01/30/2015 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202880Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202880Orig1s003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202880Orig1s003SumR.pdf | |
08/19/2014 | SUPPL-2 | Labeling-Package Insert, REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202880s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202880Orig1s002ltr.pdf | |
09/22/2014 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/04/2021 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202880s020lbl.pdf | |
10/07/2019 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202880s019lbl.pdf | |
10/07/2019 | SUPPL-19 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202880s019lbl.pdf | |
09/18/2018 | SUPPL-15 | REMS | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202880s014s015lbl.pdf | |
09/18/2018 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202880s014s015lbl.pdf | |
09/18/2018 | SUPPL-14 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202880s014s015lbl.pdf | |
12/16/2016 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202880s009s010lbl.pdf | |
12/16/2016 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202880s009s010lbl.pdf | |
12/16/2016 | SUPPL-9 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202880s009s010lbl.pdf | |
01/30/2015 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202880Orig1s003lbl.pdf | |
08/19/2014 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202880s002lbl.pdf | |
08/19/2014 | SUPPL-2 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202880s002lbl.pdf | |
10/25/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202880s000lbl.pdf |