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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070299
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NALOXONE NALOXONE HYDROCHLORIDE 0.4MG/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
10/22/1985 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
03/12/2015 SUPPL-17 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
09/14/2000 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.
01/25/1999 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
01/25/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
09/26/1997 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
08/26/1996 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
11/18/1993 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
07/27/1993 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
03/26/1993 SUPPL-9 Labeling

Label is not available on this site.
09/25/1990 SUPPL-7 Labeling

Label is not available on this site.
02/22/1990 SUPPL-6 Labeling

Label is not available on this site.
07/20/1989 SUPPL-5 Labeling

Label is not available on this site.
12/19/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
11/03/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
01/29/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
01/29/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

NALOXONE

INJECTABLE;INJECTION; 0.4MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NALOXONE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 070299 HIKMA
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 216624 ACCORD HLTHCARE
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 214785 BAXTER HLTHCARE CORP
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 214792 BAXTER HLTHCARE CORP
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 212455 EUGIA PHARMA
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 212456 EUGIA PHARMA
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 213573 FRESENIUS KABI USA
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 212300 HIKMA
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 070172 HOSPIRA
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 070256 HOSPIRA
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 070257 HOSPIRA
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 218404 MANKIND PHARMA
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 204997 MYLAN INSTITUTIONAL
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 205014 MYLAN INSTITUTIONAL
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 208871 RISING
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 208872 RISING
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 207633 SOMERSET THERAPS LLC
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 207634 SOMERSET THERAPS LLC
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