Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016812
Company: PAR STERILE PRODUCTS
Company: PAR STERILE PRODUCTS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KETALAR | KETAMINE HYDROCHLORIDE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| KETALAR | KETAMINE HYDROCHLORIDE | EQ 50MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| KETALAR | KETAMINE HYDROCHLORIDE | EQ 100MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/03/2022 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/016812s051lbl.pdf | |
| 08/24/2020 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/016812Orig1s046lbl.pdf | |
| 08/07/2018 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016812s040lbl.pdf | |
| 04/27/2017 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016812s043lbl.pdf | |
| 03/07/2012 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016812s039lbl.pdf |