Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022556
Company: AYTU
Company: AYTU
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
KARBINAL ER | CARBINOXAMINE MALEATE | 4MG/5ML | SUSPENSION, EXTENDED RELEASE;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/28/2013 | 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/2013/022556s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022556Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022556Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022556Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/25/2021 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022556s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022556Orig1s006ltr.pdf | |
05/12/2016 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/02/2015 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/10/2015 | 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 |
---|---|---|---|---|---|
03/25/2021 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022556s006lbl.pdf | |
03/28/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022556s000lbl.pdf |