Nafcillin Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sagent Pharmaceuticals (2015-10-13)
Oldest Current Product
1984-08-02
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\NAFCILLIN
FDAOB
INJECTION\INJECTION\NAFCILLIN SODIUM\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\NAFCILLIN SODIUM
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\NAFCILLIN

product(s) by strength(s)

nafcillin 100 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007813126ANDASandoz Inc1984-08-02NAFCILLIN SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA062527a7c673fe-9a8c-4f32-aea8-0bac4f6c7fa1
2007819126ANDASandoz Inc1984-08-02NAFCILLIN SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0625274c261602-21b1-408f-9b2f-7b12cea8cd52
3250210141ANDASagent Pharmaceuticals2012-10-25NAFCILLIN SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0905805a501234-5e1c-441f-be97-97add6eabb13
4445670223ANDAWg Critical Care, Llc2011-04-27NAFCILLIN SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA09000577999cd2-17b8-4df9-b687-d0f9b62096b9
5551500124ANDAAuromedics Pharma Llc2012-12-26NAFCILLIN SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0916140f21384c-0f82-4d99-a05c-6773d1ee4bcf, 8ec288e6-4d7f-4fea-a5ab-f9f337ebaa86
6633230330ANDAApp Pharmaceuticals, Llc2011-04-27NAFCILLIN SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA090005bbf0d8e4-b8e4-4958-b6b6-f0b9960f3b6a

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA061984NAFCILLIN SODIUMTrueAPOTHECON INC DIV BRISTOL MYERS SQUIBBANDA061984_001, ANDA061984_002, ANDA061984_003, ANDA061984_005Nafcillin Injection
2ANDA061999NALLPENTrueGLAXOSMITHKLINEANDA061999_001, ANDA061999_002, ANDA061999_003, ANDA061999_004Nafcillin Injection
3ANDA062527NAFCILLIN SODIUMSANDOZ INC1984-08-02ANDA062527_001, ANDA062527_002, ANDA062527_003, ANDA062527_004Nafcillin Injection
4ANDA062717UNIPENTrueWYETH AYERST LABORATORIES1986-12-16ANDA062717_001, ANDA062717_002, ANDA062717_004Nafcillin Injection
5ANDA062732NAFCILLIN SODIUMSANDOZ INC1986-12-23ANDA062732_001, ANDA062732_002Nafcillin Injection
6ANDA062755NALLPENTrueGLAXOSMITHKLINE1986-12-19ANDA062755_001, ANDA062755_002Nafcillin Injection
7ANDA062844NAFCILLIN SODIUMTrueWATSON LABORATORIES INC1988-10-26ANDA062844_001, ANDA062844_002, ANDA062844_003, ANDA062844_004, ANDA062844_005Nafcillin Injection
8ANDA063008NAFCILLIN SODIUMTrueWATSON LABORATORIES INC1988-09-29ANDA063008_001Nafcillin Injection
9ANDA090002NAFCILLIN SODIUMISTITUTO BIOCHIMICO ITALIANO SPA2011-06-30ANDA090002_001, ANDA090002_002Nafcillin Injection
10ANDA090005NAFCILLIN SODIUMISTITUTO BIOCHIMICO ITALIANO SPA2011-04-20ANDA090005_001Nafcillin Injection
11ANDA090560NAFCILLIN SODIUMANTIBIOTICE SA2011-10-03ANDA090560_001, ANDA090560_002Nafcillin Injection
12ANDA090580NAFCILLIN SODIUMSAGENT PHARMACEUTICALS INC2012-08-24ANDA090580_001Nafcillin Injection
13ANDA090582NAFCILLIN SODIUMSAGENT PHARMACEUTICALS INC2012-08-24ANDA090582_001, ANDA090582_002Nafcillin Injection
14ANDA091613NAFCILLIN SODIUMAUROBINDO PHARMA LTD2012-12-26ANDA091613_001, ANDA091613_002Nafcillin Injection
15ANDA091614NAFCILLIN SODIUMAUROBINDO PHARMA LTD2012-12-26ANDA091614_001Nafcillin Injection
16ANDA200002NAFCILLIN SODIUMMYLAN LABORATORIES LTD2014-04-07ANDA200002_001, ANDA200002_002Nafcillin Injection
17NDA050320UNIPENTrueWYETH AYERST LABORATORIESNDA050320_001, NDA050320_002, NDA050320_003, NDA050320_004, NDA050320_005, NDA050320_006Nafcillin Injection
18NDA050655NALLPEN IN PLASTIC CONTAINERBAXTER HEALTHCARE CORP1989-10-31NDA050655_001, NDA050655_002Nafcillin Injection

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA061984_001discontinuedNAFCILLIN SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseNAFCILLIN SODIUM
2ANDA061984_002discontinuedNAFCILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseNAFCILLIN SODIUM
3ANDA061984_003discontinuedNAFCILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseNAFCILLIN SODIUM
4ANDA061984_005discontinuedNAFCILLIN SODIUM (EQ 4GM BASE/VIAL)INJECTIONFalseNAFCILLIN SODIUM
5ANDA061999_001discontinuedNAFCILLIN SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseNALLPEN
6ANDA061999_002discontinuedNAFCILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseNALLPEN
7ANDA061999_003discontinuedNAFCILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseNALLPEN
8ANDA061999_004discontinuedNAFCILLIN SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalseNALLPEN
9ANDA062527_001discontinuedNAFCILLIN SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalse1984-08-02NAFCILLIN SODIUM
10ANDA062527_002RXNAFCILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONTrueAP1984-08-02NAFCILLIN SODIUM
11ANDA062527_003RXNAFCILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONTrueAP1984-08-02NAFCILLIN SODIUM
12ANDA062527_004RXNAFCILLIN SODIUM (EQ 10GM BASE/VIAL)INJECTIONTrueAP1984-08-02NAFCILLIN SODIUM
13ANDA062717_001discontinuedNAFCILLIN SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalse1986-12-16UNIPEN
14ANDA062717_002discontinuedNAFCILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalse1986-12-16UNIPEN
15ANDA062717_004discontinuedNAFCILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalse1986-12-16UNIPEN
16ANDA062732_001RXNAFCILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONTrueAP1986-12-23NAFCILLIN SODIUM
17ANDA062732_002RXNAFCILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONTrueAP1986-12-23NAFCILLIN SODIUM
18ANDA062755_001discontinuedNAFCILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalse1986-12-19NALLPEN
19ANDA062755_002discontinuedNAFCILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalse1986-12-19NALLPEN
20ANDA062844_001discontinuedNAFCILLIN SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalse1988-10-26NAFCILLIN SODIUM
21ANDA062844_002discontinuedNAFCILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalse1988-10-26NAFCILLIN SODIUM
22ANDA062844_003discontinuedNAFCILLIN SODIUM (EQ 1.5GM BASE/VIAL)INJECTIONFalse1988-10-26NAFCILLIN SODIUM
23ANDA062844_004discontinuedNAFCILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalse1988-10-26NAFCILLIN SODIUM
24ANDA062844_005discontinuedNAFCILLIN SODIUM (EQ 4GM BASE/VIAL)INJECTIONFalse1988-10-26NAFCILLIN SODIUM
25ANDA063008_001discontinuedNAFCILLIN SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalse1988-09-29NAFCILLIN SODIUM
26ANDA090002_001RXNAFCILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2011-06-30NAFCILLIN SODIUM
27ANDA090002_002RXNAFCILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2011-06-30NAFCILLIN SODIUM
28ANDA090005_001RXNAFCILLIN SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalseAP2011-04-20NAFCILLIN SODIUM
29ANDA090560_001RXNAFCILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2011-10-03NAFCILLIN SODIUM
30ANDA090560_002RXNAFCILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2011-10-03NAFCILLIN SODIUM
31ANDA090580_001RXNAFCILLIN SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalseAP2012-08-24NAFCILLIN SODIUM
32ANDA090582_001RXNAFCILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2012-08-24NAFCILLIN SODIUM
33ANDA090582_002RXNAFCILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2012-08-24NAFCILLIN SODIUM
34ANDA091613_001RXNAFCILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2012-12-26NAFCILLIN SODIUM
35ANDA091613_002RXNAFCILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2012-12-26NAFCILLIN SODIUM
36ANDA091614_001RXNAFCILLIN SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalseAP2012-12-26NAFCILLIN SODIUM
37ANDA200002_001RXNAFCILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2014-04-07NAFCILLIN SODIUM
38ANDA200002_002RXNAFCILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2014-04-07NAFCILLIN SODIUM
39NDA050320_001discontinuedNAFCILLIN SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseUNIPEN
40NDA050320_002discontinuedNAFCILLIN SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseUNIPEN
41NDA050320_003discontinuedNAFCILLIN SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseUNIPEN
42NDA050320_004discontinuedNAFCILLIN SODIUM (EQ 4GM BASE/VIAL)INJECTIONFalseUNIPEN
43NDA050320_005discontinuedNAFCILLIN SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalseUNIPEN
44NDA050320_006discontinuedNAFCILLIN SODIUM (EQ 20GM BASE/VIAL)INJECTIONFalseUNIPEN
45NDA050655_001RXNAFCILLIN SODIUM (EQ 20MG BASE/ML)INJECTIONTrue1989-10-31NALLPEN IN PLASTIC CONTAINER
46NDA050655_002RXNAFCILLIN SODIUM (EQ 2GM BASE/100ML)INJECTIONTrue1989-10-31NALLPEN IN PLASTIC CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10f21384c-0f82-4d99-a05c-6773d1ee4bcf (view SPL)NAFCILLIN FOR INJECTION, USPprescriptionHuman PrescriptionAuromedics Pharma LlcANALYSIS, API MANUFACTURE, MANUFACTURE2014-12-251551500124
24c261602-21b1-408f-9b2f-7b12cea8cd52 (view SPL)Nafcillin for Injection, USPprescriptionHuman PrescriptionSandoz Inc2015-09-3013007819126
35a501234-5e1c-441f-be97-97add6eabb13 (view SPL)Nafcillin for Injection, USPprescriptionHuman PrescriptionSagent Pharmaceuticals2015-10-139250210141
477999cd2-17b8-4df9-b687-d0f9b62096b9 (view SPL)Nafcillin For Injection, USPprescriptionHuman PrescriptionWg Critical Care, LlcMANUFACTURE2015-04-082445670223
58ec288e6-4d7f-4fea-a5ab-f9f337ebaa86 (view SPL)prescriptionHuman PrescriptionAuromedics Pharma LlcANALYSIS, API MANUFACTURE, MANUFACTURE2014-01-025551500124
6a7c673fe-9a8c-4f32-aea8-0bac4f6c7fa1 (view SPL)Nafcillin for Injection, USPprescriptionHuman PrescriptionSandoz Inc2015-09-3013007813126
7bbf0d8e4-b8e4-4958-b6b6-f0b9960f3b6a (view SPL)Nafcillin For InjectionprescriptionHuman PrescriptionApp Pharmaceuticals, Llcmanufacture2013-03-013633230330

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