Drugs@FDA: FDA-Approved Drugs
Company: ENDO OPERATIONS
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 |
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 | ENDO OPERATIONS |
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 | 215808 | FRESENIUS KABI USA |
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 | ENDO OPERATIONS |
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 | 215808 | FRESENIUS KABI USA |
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 | ENDO OPERATIONS |
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 |