Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202144
Company: ACTAVIS LABS FL INC
Company: ACTAVIS LABS FL INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 12MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 16MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 32MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | 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 |
---|---|---|---|---|---|---|---|
05/12/2014 | ORIG-1 | Approval | Not Applicable |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202144Orig1s000lbl&MG.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202144Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/18/2018 | SUPPL-15 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
11/07/2017 | SUPPL-14 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
05/26/2017 | SUPPL-13 | REMS-Modified |
Label is not available on this site. |
||
09/30/2016 | SUPPL-10 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
04/20/2016 | SUPPL-8 | REMS-Modified |
Label is not available on this site. |
||
06/26/2015 | SUPPL-7 | REMS-Modified |
Label is not available on this site. |
||
06/30/2016 | SUPPL-6 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202144s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202144Orig1s006ltr.pdf | |
08/19/2014 | SUPPL-5 | REMS-Modified |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/30/2016 | SUPPL-6 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202144s006lbl.pdf |
05/12/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202144Orig1s000lbl&MG.pdf |
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