Naloxone Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2014-07-08)
Oldest Current Product
1987-01-07
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\NALOXONE
FDAOB
INJECTION\INJECTION\NALOXONE HYDROCHLORIDE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\NALOXONE HYDROCHLORIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\NALOXONE

product(s) by strength(s)

naloxone hydrochloride 0.4 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091219ANDAHospira, Inc.1987-01-07, 2014-04-09NALOXONE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA0702578535cc84-ad4a-4d67-8480-fb5a2e3406f8, be337cb8-4026-45d2-a0bd-0801e5488a8e

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551544732ANDACardinal Health2011-07-08NALOXONE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION004091219ANDA0702563ce7dbb4-3d14-43f0-80d6-0deb79a7aea6

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA070171NALOXONE HYDROCHLORIDETrueHOSPIRA INC1986-09-24ANDA070171_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
2ANDA070172NALOXONE HYDROCHLORIDEHOSPIRA INC1986-09-24ANDA070172_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
3ANDA070188NALOXONETrueWYETH AYERST LABORATORIES1986-09-24ANDA070188_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
4ANDA070189NALOXONETrueWYETH AYERST LABORATORIES1986-09-24ANDA070189_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
5ANDA070190NALOXONETrueWYETH AYERST LABORATORIES1986-09-24ANDA070190_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
6ANDA070191NALOXONETrueWYETH AYERST LABORATORIES1986-09-24ANDA070191_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
7ANDA070252NALOXONE HYDROCHLORIDETrueHOSPIRA INC1987-01-16ANDA070252_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
8ANDA070253NALOXONE HYDROCHLORIDETrueHOSPIRA INC1987-01-16ANDA070253_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
9ANDA070254NALOXONE HYDROCHLORIDEHOSPIRA INC1987-01-07ANDA070254_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
10ANDA070255NALOXONE HYDROCHLORIDETrueHOSPIRA INC1987-01-07ANDA070255_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
11ANDA070256NALOXONE HYDROCHLORIDEHOSPIRA INC1987-01-07ANDA070256_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
12ANDA070257NALOXONE HYDROCHLORIDEHOSPIRA INC1987-01-07ANDA070257_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
13ANDA070298NALOXONETrueHIKMA MAPLE LTD1986-09-24ANDA070298_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
14ANDA070299NALOXONETrueEUROHEALTH INTERNATIONAL SARL1986-09-24ANDA070299_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
15ANDA070417NALOXONE HYDROCHLORIDETrueINTERNATIONAL MEDICATION SYSTEMS LTD1986-09-24ANDA070417_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
16ANDA070496NALOXONETrueHIKMA MAPLE LTD1986-09-24ANDA070496_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
17ANDA070639NALOXONE HYDROCHLORIDEINTERNATIONAL MEDICATION SYSTEM1986-09-24ANDA070639_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
18ANDA070648NALOXONE HYDROCHLORIDETrueABRAXIS PHARMACEUTICAL PRODUCTS1986-11-17ANDA070648_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
19ANDA070649NALOXONE HYDROCHLORIDETrueABRAXIS PHARMACEUTICAL PRODUCTS1986-11-17ANDA070649_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
20ANDA070661NALOXONE HYDROCHLORIDETrueABRAXIS PHARMACEUTICAL PRODUCTS1986-11-17ANDA070661_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
21ANDA071083NARCANTrueBRISTOL MYERS SQUIBB PHARMA CO1988-07-28ANDA071083_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
22ANDA071084NARCANTrueBRISTOL MYERS SQUIBB PHARMA CO1988-07-28ANDA071084_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
23ANDA071272NALOXONE HYDROCHLORIDETrueHIKMA MAPLE LTD1988-05-24ANDA071272_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
24ANDA071273NALOXONE HYDROCHLORIDETrueHIKMA MAPLE LTD1988-05-24ANDA071273_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
25ANDA071274NALOXONE HYDROCHLORIDETrueHIKMA MAPLE LTD1988-05-24ANDA071274_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
26ANDA071287NALOXONE HYDROCHLORIDETrueHIKMA MAPLE LTD1988-05-24ANDA071287_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
27ANDA071311NARCANTrueBRISTOL MYERS SQUIBB PHARMA CO1988-07-28ANDA071311_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
28ANDA071339NALOXONE HYDROCHLORIDETrueWATSON LABORATORIES INC1987-11-18ANDA071339_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
29ANDA071604NALOXONE HYDROCHLORIDETrueABRAXIS PHARMACEUTICAL PRODUCTS1988-12-16ANDA071604_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
30ANDA071671NALOXONE HYDROCHLORIDETrueSMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW1987-11-17ANDA071671_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
31ANDA071672NALOXONE HYDROCHLORIDETrueSOLOPAK MEDICAL PRODUCTS INC1987-11-17ANDA071672_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
32ANDA071681NALOXONE HYDROCHLORIDETrueSMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW1987-11-17ANDA071681_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
33ANDA071682NALOXONE HYDROCHLORIDETrueSMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW1987-11-17ANDA071682_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
34ANDA071683NALOXONE HYDROCHLORIDETrueSOLOPAK MEDICAL PRODUCTS INC1987-11-17ANDA071683_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
35ANDA071811NALOXONE HYDROCHLORIDETrueMARSAM PHARMACEUTICALS LLC1988-07-19ANDA071811_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
36ANDA072076NALOXONE HYDROCHLORIDEINTERNATIONAL MEDICATION SYSTEM1988-03-24ANDA072076_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
37ANDA072081NALOXONE HYDROCHLORIDETrueASTRAZENECA LP1989-04-11ANDA072081_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
38ANDA072082NALOXONE HYDROCHLORIDETrueIGI LABORATORIES INC1989-04-11ANDA072082_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
39ANDA072083NALOXONE HYDROCHLORIDETrueIGI LABORATORIES INC1989-04-11ANDA072083_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
40ANDA072084NALOXONE HYDROCHLORIDETrueIGI LABORATORIES INC1989-04-11ANDA072084_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
41ANDA072085NALOXONE HYDROCHLORIDETrueIGI LABORATORIES INC1989-04-11ANDA072085_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
42ANDA072086NALOXONE HYDROCHLORIDETrueIGI LABORATORIES INC1989-04-11ANDA072086_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
43ANDA072087NALOXONE HYDROCHLORIDETrueIGI LABORATORIES INC1989-04-11ANDA072087_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
44ANDA072088NALOXONE HYDROCHLORIDETrueIGI LABORATORIES INC1989-04-11ANDA072088_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
45ANDA072089NALOXONE HYDROCHLORIDETrueIGI LABORATORIES INC1989-04-11ANDA072089_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
46ANDA072090NALOXONE HYDROCHLORIDETrueIGI LABORATORIES INC1989-04-11ANDA072090_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
47ANDA072091NALOXONE HYDROCHLORIDETrueIGI LABORATORIES INC1989-04-11ANDA072091_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
48ANDA072092NALOXONE HYDROCHLORIDETrueIGI LABORATORIES INC1989-04-11ANDA072092_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
49ANDA072093NALOXONE HYDROCHLORIDETrueIGI LABORATORIES INC1989-04-11ANDA072093_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
50ANDA072115NALOXONE HYDROCHLORIDETrueINTERNATIONAL MEDICATION SYSTEMS LTD1988-04-27ANDA072115_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
51ANDA204997NALOXONE HYDROCHLORIDEMYLAN INSTITUTIONAL LLC2014-03-06ANDA204997_001Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge
52NDA016636NARCANTrueADAPT PHARMA OPERATIONS LTDNDA016636_001, NDA016636_002, NDA016636_003Naloxone Injection
Naloxone Prefilled Syringe
Naloxone Cartridge

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA070171_001discontinuedNALOXONE HYDROCHLORIDE (0.02MG/ML)INJECTIONFalse1986-09-24NALOXONE HYDROCHLORIDE
2ANDA070172_001RXNALOXONE HYDROCHLORIDE (0.4MG/ML)INJECTIONTrueAP1986-09-24NALOXONE HYDROCHLORIDE
3ANDA070188_001discontinuedNALOXONE HYDROCHLORIDE (0.02MG/ML)INJECTIONFalse1986-09-24NALOXONE
4ANDA070189_001discontinuedNALOXONE HYDROCHLORIDE (0.02MG/ML)INJECTIONFalse1986-09-24NALOXONE
5ANDA070190_001discontinuedNALOXONE HYDROCHLORIDE (0.4MG/ML)INJECTIONFalse1986-09-24NALOXONE
6ANDA070191_001discontinuedNALOXONE HYDROCHLORIDE (0.4MG/ML)INJECTIONFalse1986-09-24NALOXONE
7ANDA070252_001discontinuedNALOXONE HYDROCHLORIDE (0.02MG/ML)INJECTIONFalse1987-01-16NALOXONE HYDROCHLORIDE
8ANDA070253_001discontinuedNALOXONE HYDROCHLORIDE (0.02MG/ML)INJECTIONFalse1987-01-16NALOXONE HYDROCHLORIDE
9ANDA070254_001RXNALOXONE HYDROCHLORIDE (0.4MG/ML)INJECTIONTrueAP1987-01-07NALOXONE HYDROCHLORIDE
10ANDA070255_001discontinuedNALOXONE HYDROCHLORIDE (0.4MG/ML)INJECTIONFalse1987-01-07NALOXONE HYDROCHLORIDE
11ANDA070256_001RXNALOXONE HYDROCHLORIDE (0.4MG/ML)INJECTIONTrueAP1987-01-07NALOXONE HYDROCHLORIDE
12ANDA070257_001RXNALOXONE HYDROCHLORIDE (0.4MG/ML)INJECTIONTrueAP1987-01-07NALOXONE HYDROCHLORIDE
13ANDA070298_001discontinuedNALOXONE HYDROCHLORIDE (0.4MG/ML)INJECTIONFalse1986-09-24NALOXONE
14ANDA070299_001discontinuedNALOXONE HYDROCHLORIDE (0.4MG/ML)INJECTIONFalse1986-09-24NALOXONE
15ANDA070417_001discontinuedNALOXONE HYDROCHLORIDE (0.4MG/ML)INJECTIONFalse1986-09-24NALOXONE HYDROCHLORIDE
16ANDA070496_001discontinuedNALOXONE HYDROCHLORIDE (0.4MG/ML)INJECTIONFalse1986-09-24NALOXONE
17ANDA070639_001RXNALOXONE HYDROCHLORIDE (0.4MG/ML)INJECTIONFalseAP1986-09-24NALOXONE HYDROCHLORIDE
18ANDA070648_001discontinuedNALOXONE HYDROCHLORIDE (0.02MG/ML)INJECTIONFalse1986-11-17NALOXONE HYDROCHLORIDE
19ANDA070649_001discontinuedNALOXONE HYDROCHLORIDE (0.4MG/ML)INJECTIONFalse1986-11-17NALOXONE HYDROCHLORIDE
20ANDA070661_001discontinuedNALOXONE HYDROCHLORIDE (0.02MG/ML)INJECTIONFalse1986-11-17NALOXONE HYDROCHLORIDE
21ANDA071083_001discontinuedNALOXONE HYDROCHLORIDE (0.4MG/ML)INJECTIONFalse1988-07-28NARCAN
22ANDA071084_001discontinuedNALOXONE HYDROCHLORIDE (1MG/ML)INJECTIONFalse1988-07-28NARCAN
23ANDA071272_001discontinuedNALOXONE HYDROCHLORIDE (0.02MG/ML)INJECTIONFalse1988-05-24NALOXONE HYDROCHLORIDE
24ANDA071273_001discontinuedNALOXONE HYDROCHLORIDE (1MG/ML)INJECTIONFalse1988-05-24NALOXONE HYDROCHLORIDE
25ANDA071274_001discontinuedNALOXONE HYDROCHLORIDE (1MG/ML)INJECTIONFalse1988-05-24NALOXONE HYDROCHLORIDE
26ANDA071287_001discontinuedNALOXONE HYDROCHLORIDE (1MG/ML)INJECTIONFalse1988-05-24NALOXONE HYDROCHLORIDE
27ANDA071311_001discontinuedNALOXONE HYDROCHLORIDE (1MG/ML)INJECTIONFalse1988-07-28NARCAN
28ANDA071339_001discontinuedNALOXONE HYDROCHLORIDE (0.4MG/ML)INJECTIONFalse1987-11-18NALOXONE HYDROCHLORIDE
29ANDA071604_001discontinuedNALOXONE HYDROCHLORIDE (1MG/ML)INJECTIONFalse1988-12-16NALOXONE HYDROCHLORIDE
30ANDA071671_001discontinuedNALOXONE HYDROCHLORIDE (0.02MG/ML)INJECTIONFalse1987-11-17NALOXONE HYDROCHLORIDE
31ANDA071672_001discontinuedNALOXONE HYDROCHLORIDE (0.02MG/ML)INJECTIONFalse1987-11-17NALOXONE HYDROCHLORIDE
32ANDA071681_001discontinuedNALOXONE HYDROCHLORIDE (0.4MG/ML)INJECTIONFalse1987-11-17NALOXONE HYDROCHLORIDE
33ANDA071682_001discontinuedNALOXONE HYDROCHLORIDE (0.4MG/ML)INJECTIONFalse1987-11-17NALOXONE HYDROCHLORIDE
34ANDA071683_001discontinuedNALOXONE HYDROCHLORIDE (0.4MG/ML)INJECTIONFalse1987-11-17NALOXONE HYDROCHLORIDE
35ANDA071811_001discontinuedNALOXONE HYDROCHLORIDE (0.4MG/ML)INJECTIONFalse1988-07-19NALOXONE HYDROCHLORIDE
36ANDA072076_001RXNALOXONE HYDROCHLORIDE (1MG/ML)INJECTIONTrueAP1988-03-24NALOXONE HYDROCHLORIDE
37ANDA072081_001discontinuedNALOXONE HYDROCHLORIDE (0.02MG/ML)INJECTIONFalse1989-04-11NALOXONE HYDROCHLORIDE
38ANDA072082_001discontinuedNALOXONE HYDROCHLORIDE (0.02MG/ML)INJECTIONFalse1989-04-11NALOXONE HYDROCHLORIDE
39ANDA072083_001discontinuedNALOXONE HYDROCHLORIDE (0.02MG/ML)INJECTIONFalse1989-04-11NALOXONE HYDROCHLORIDE
40ANDA072084_001discontinuedNALOXONE HYDROCHLORIDE (0.02MG/ML)INJECTIONFalse1989-04-11NALOXONE HYDROCHLORIDE
41ANDA072085_001discontinuedNALOXONE HYDROCHLORIDE (0.02MG/ML)INJECTIONFalse1989-04-11NALOXONE HYDROCHLORIDE
42ANDA072086_001discontinuedNALOXONE HYDROCHLORIDE (0.4MG/ML)INJECTIONFalse1989-04-11NALOXONE HYDROCHLORIDE
43ANDA072087_001discontinuedNALOXONE HYDROCHLORIDE (0.4MG/ML)INJECTIONFalse1989-04-11NALOXONE HYDROCHLORIDE
44ANDA072088_001discontinuedNALOXONE HYDROCHLORIDE (0.4MG/ML)INJECTIONFalse1989-04-11NALOXONE HYDROCHLORIDE
45ANDA072089_001discontinuedNALOXONE HYDROCHLORIDE (0.4MG/ML)INJECTIONFalse1989-04-11NALOXONE HYDROCHLORIDE
46ANDA072090_001discontinuedNALOXONE HYDROCHLORIDE (0.4MG/ML)INJECTIONFalse1989-04-11NALOXONE HYDROCHLORIDE
47ANDA072091_001discontinuedNALOXONE HYDROCHLORIDE (1MG/ML)INJECTIONFalse1989-04-11NALOXONE HYDROCHLORIDE
48ANDA072092_001discontinuedNALOXONE HYDROCHLORIDE (1MG/ML)INJECTIONFalse1989-04-11NALOXONE HYDROCHLORIDE
49ANDA072093_001discontinuedNALOXONE HYDROCHLORIDE (1MG/ML)INJECTIONFalse1989-04-11NALOXONE HYDROCHLORIDE
50ANDA072115_001discontinuedNALOXONE HYDROCHLORIDE (1MG/ML)INJECTIONFalse1988-04-27NALOXONE HYDROCHLORIDE
51ANDA204997_001RXNALOXONE HYDROCHLORIDE (0.4MG/ML)INJECTIONFalseAP2014-03-06NALOXONE HYDROCHLORIDE
52NDA016636_001discontinuedNALOXONE HYDROCHLORIDE (0.4MG/ML)INJECTIONFalseNARCAN
53NDA016636_002discontinuedNALOXONE HYDROCHLORIDE (0.02MG/ML)INJECTIONFalseNARCAN
54NDA016636_003discontinuedNALOXONE HYDROCHLORIDE (1MG/ML)INJECTIONFalse1982-06-14NARCAN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
13ce7dbb4-3d14-43f0-80d6-0deb79a7aea6 (view SPL)NALOXONE HYDROCHLORIDEprescriptionHuman PrescriptionCardinal HealthREPACK2013-09-163551544732, 551546980Naloxone Injection
28535cc84-ad4a-4d67-8480-fb5a2e3406f8 (view SPL)NALOXONE HYDROCHLORIDEprescriptionHuman PrescriptionHospira, Inc.2013-10-2312004091219, 004091212, 004091215Naloxone Injection
3be337cb8-4026-45d2-a0bd-0801e5488a8e (view SPL)Naloxone HydrochlorideprescriptionHuman PrescriptionHospira, Inc.analysis, api manufacture, manufacture2014-07-081004091219, 004091215Naloxone Injection

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII