Drugs@FDA: FDA-Approved Drugs
Company: MIKART
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;2.5MG | TABLET;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 |
---|---|---|---|---|---|---|---|
06/09/2010 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/05/2021 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
10/28/2019 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
09/21/2018 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
09/18/2018 | SUPPL-11 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
08/24/2018 | SUPPL-10 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
12/16/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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12/16/2016 | SUPPL-8 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
12/15/2016 | SUPPL-6 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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10/18/2013 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/040432s006,40556s012,40658s006, 40846s005, 89699s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/040432s006,040556s012,040658s006,040846s005,089699s044ltr.pdf | |
05/12/2014 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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06/24/2011 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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08/25/2010 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/18/2013 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/040432s006,40556s012,40658s006, 40846s005, 89699s044lbl.pdf |