Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074549
Company: HOSPIRA
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 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
06/27/1996 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
07/19/2021 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

04/28/2020 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

11/07/2017 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

06/13/2013 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

08/10/2004 SUPPL-7 Labeling

Label is not available on this site.

11/24/2003 SUPPL-4 Labeling

Label is not available on this site.

02/14/2001 SUPPL-3 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/13/1999 SUPPL-2 Labeling

Label is not available on this site.

08/24/1999 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 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 074549 HOSPIRA
KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription No AP 074524 WEST-WARD PHARMS INT

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 074549 HOSPIRA
KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription No AP 074524 WEST-WARD PHARMS INT

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English