Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074524
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
KETAMINE HYDROCHLORIDE | KETAMINE HYDROCHLORIDE | EQ 50MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
KETAMINE HYDROCHLORIDE | KETAMINE HYDROCHLORIDE | EQ 100MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | 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 |
---|---|---|---|---|---|---|---|
03/22/1996 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/12/2023 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
04/07/2021 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
06/03/2020 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
06/03/2020 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
10/11/2012 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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04/03/2001 | SUPPL-3 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
09/24/1999 | SUPPL-1 | Labeling |
Label is not available on this site. |
KETAMINE HYDROCHLORIDE
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 |