Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076092
Company: EUGIA PHARMA
Company: EUGIA PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
KETAMINE HYDROCHLORIDE | KETAMINE HYDROCHLORIDE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
KETAMINE HYDROCHLORIDE | KETAMINE HYDROCHLORIDE | EQ 50MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
KETAMINE HYDROCHLORIDE | KETAMINE HYDROCHLORIDE | EQ 100MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | 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 |
---|---|---|---|---|---|---|---|
12/28/2001 | ORIG-1 | Approval |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76092.apdf.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/076092_s000_KetamineTOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/23/2023 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
12/31/2018 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
10/05/2012 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
09/30/2008 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
10/25/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
10/25/2002 | SUPPL-1 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
KETAMINE HYDROCHLORIDE
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 | 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 | 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 |