U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 016812
Company: PH HEALTH

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 No
KETALAR KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription AP Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/23/2026 SUPPL-57 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/016812s057lbl.pdf
10/29/2025 SUPPL-56 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/016812s056lbl.pdf
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
Back to Top