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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016812
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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/19/1970 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/23/2022 SUPPL-52 Manufacturing (CMC)-Facility Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/016812Orig1s052Correctedltr.pdf
06/03/2022 SUPPL-51 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/016812s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/016812Orig1s051ltr.pdf
08/24/2020 SUPPL-46 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/016812Orig1s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/016812Orig1s046ltr.pdf
04/27/2017 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016812s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/016812Orig1s043ltr.pdf
08/07/2018 SUPPL-40 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016812s040lbl.pdf
03/07/2012 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016812s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016812s039ltr.pdf
11/14/2002 SUPPL-32 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16812slr032ltr.pdf
03/29/2000 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.
03/14/2000 SUPPL-29 Labeling

Label is not available on this site.
11/17/1998 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.
09/05/1997 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.
02/14/2001 SUPPL-26 Labeling

Label is not available on this site.
11/29/1994 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.
02/07/1989 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.
06/11/1982 SUPPL-23 Efficacy

Label is not available on this site.
08/18/1980 SUPPL-22 Labeling

Label is not available on this site.
04/04/1980 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.
04/04/1980 SUPPL-20 Labeling

Label is not available on this site.
07/05/1977 SUPPL-19 Labeling

Label is not available on this site.
05/16/1977 SUPPL-18 Labeling

Label is not available on this site.
05/16/1977 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.
01/28/1977 SUPPL-15 Labeling

Label is not available on this site.
05/14/1976 SUPPL-14 Labeling

Label is not available on this site.

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

KETALAR

INJECTABLE;INJECTION; EQ 10MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KETALAR KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 016812 PAR STERILE PRODUCTS
KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076092 EUGIA PHARMA
KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 216809 GLAND PHARMA LTD

INJECTABLE;INJECTION; EQ 50MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KETALAR KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 016812 PAR STERILE PRODUCTS
KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076092 EUGIA PHARMA
KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription No AP 216809 GLAND PHARMA LTD
KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription No AP 074524 HIKMA
KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription No AP 074549 HOSPIRA

INJECTABLE;INJECTION; EQ 100MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KETALAR KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 016812 PAR STERILE PRODUCTS
KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076092 EUGIA PHARMA
KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription No AP 216809 GLAND PHARMA LTD
KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription No AP 074524 HIKMA
KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription No AP 074549 HOSPIRA
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