isoniazid Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sandoz Inc (2009-08-14)
Oldest Current Product
2006-01-19
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\ISONIAZID
FDAOB
INJECTION\INJECTION\ISONIAZID\rdfq
ORAL\SYRUP\ISONIAZID
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\ISONIAZID
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\ISONIAZID

product(s) by strength(s)

isoniazid 100 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007813056ANDASandoz Inc2006-01-19ISONIAZIDINTRAMUSCULARINJECTION, SOLUTIONANDA04064877795c31-1cdf-4a20-b4a1-cd15f5b310f1

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA040648ISONIAZIDSANDOZ CANADA INC2005-07-05ANDA040648_001
2NDA008420RIMIFONTrueHOFFMANN LA ROCHE INCNDA008420_001, NDA008420_002, NDA008420_003isoniazid Oral Solution
3NDA008662NYDRAZIDTrueSANDOZ INCNDA008662_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA040648_001RXISONIAZID (100MG/ML)INJECTIONTrue2005-07-05ISONIAZID
2NDA008420_001discontinuedISONIAZID (50MG/5ML)ORALSYRUPFalseRIMIFON
3NDA008420_002discontinuedISONIAZID (25MG/ML)INJECTIONFalseRIMIFON
4NDA008420_003discontinuedISONIAZID (100MG/ML)INJECTIONFalseRIMIFON
5NDA008662_001discontinuedISONIAZID (100MG/ML)INJECTIONFalseNYDRAZID

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
177795c31-1cdf-4a20-b4a1-cd15f5b310f1 (view SPL)Isoniazid Injection, USPprescriptionHuman PrescriptionSandoz Inc2009-08-1410007813056

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