Streptomycin Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
X-Gen Pharmaceuticals, Inc. (2013-05-14)
Oldest Current Product
1998-06-30
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\STREPTOMYCIN
FDAOB
INJECTION\INJECTION\STREPTOMYCIN SULFATE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\STREPTOMYCIN SULFATE
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\STREPTOMYCIN

product(s) by strength(s)

streptomycin 400 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1398220706ANDAX-Gen Pharmaceuticals, Inc.1998-06-30STREPTOMYCIN SULFATEINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA064210abd1f64e-4283-4370-aae8-3666316aa36e

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA060076STREPTOMYCIN SULFATETruePFIZER LABORATORIES DIV PFIZER INCANDA060076_001, ANDA060076_002
2ANDA060107STREPTOMYCIN SULFATETrueELI LILLY AND COANDA060107_001, ANDA060107_002
3ANDA060111STREPTOMYCIN SULFATETruePFIZER LABORATORIES DIV PFIZER INCANDA060111_001
4ANDA060404STREPTOMYCIN SULFATETrueELI LILLY AND COANDA060404_001
5ANDA060684STREPTOMYCIN SULFATETrueJOHN D COPANOS AND CO INCANDA060684_001
6ANDA064210STREPTOMYCIN SULFATEX GEN PHARMACEUTICALS INC1998-06-30ANDA064210_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1ANDA060076_001discontinuedSTREPTOMYCIN SULFATE (EQ 1GM BASE/VIAL)INJECTIONFalseSTREPTOMYCIN SULFATE
2ANDA060076_002discontinuedSTREPTOMYCIN SULFATE (EQ 5GM BASE/VIAL)INJECTIONFalseSTREPTOMYCIN SULFATE
3ANDA060107_001discontinuedSTREPTOMYCIN SULFATE (EQ 1GM BASE/VIAL)INJECTIONFalseSTREPTOMYCIN SULFATE
4ANDA060107_002discontinuedSTREPTOMYCIN SULFATE (EQ 5GM BASE/VIAL)INJECTIONFalseSTREPTOMYCIN SULFATE
5ANDA060111_001discontinuedSTREPTOMYCIN SULFATE (EQ 1GM BASE/2.5ML)INJECTIONFalseSTREPTOMYCIN SULFATE
6ANDA060404_001discontinuedSTREPTOMYCIN SULFATE (EQ 1GM BASE/2ML)INJECTIONFalseSTREPTOMYCIN SULFATE
7ANDA060684_001discontinuedSTREPTOMYCIN SULFATE (EQ 500MG BASE/ML)INJECTIONFalseSTREPTOMYCIN SULFATE
8ANDA064210_001RXSTREPTOMYCIN SULFATE (EQ 1GM BASE/VIAL)INJECTIONTrue1998-06-30STREPTOMYCIN SULFATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1abd1f64e-4283-4370-aae8-3666316aa36e (view SPL)Streptomycin for Injection, USP Rx Only 1 gram*/vial*Each vial contains Streptomycin SulfateUSP equivalent to 1 gram Streptomycin For Intramuscular UseprescriptionHuman PrescriptionX-Gen Pharmaceuticals, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2013-05-148398220706

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