Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 207986
Company: ALK ABELLO
Company: ALK ABELLO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OTIPRIO | CIPROFLOXACIN | 6% (60MG/ML) | INJECTABLE, SUSPENSION;OTIC | 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 |
---|---|---|---|---|---|---|---|
12/10/2015 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207986s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207986Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207986Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207986Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/02/2018 | SUPPL-2 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207986s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207986Orig1s002ltr.pdf | |
01/27/2016 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207986s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207986Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/02/2018 | SUPPL-2 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207986s002lbl.pdf | |
01/27/2016 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207986s001lbl.pdf | |
12/10/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207986s000lbl.pdf |