FDA.reportPublic FDA data

Application 050638

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PENICILLIN G POTASSIUM IN PLASTIC CONTAINERPENICILLIN G POTASSIUMINJECTABLE;INJECTION20,000 UNITS/MLYesYes
002PENICILLIN G POTASSIUM IN PLASTIC CONTAINERPENICILLIN G POTASSIUMINJECTABLE;INJECTION40,000 UNITS/MLYesYes
003PENICILLIN G POTASSIUM IN PLASTIC CONTAINERPENICILLIN G POTASSIUMINJECTABLE;INJECTION60,000 UNITS/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-1021PENICILLIN G POTASSIUMPENICILLIN GBaxter Healthcare CorporationNDACurrent
0338-1021PENICILLIN G POTASSIUMPENICILLIN GBaxter Healthcare CorporationNDACurrent
0338-1021PENICILLIN G POTASSIUMPENICILLIN GBaxter Healthcare CorporationNDACurrent
0338-1021PENICILLIN G POTASSIUMPENICILLIN GBaxter Healthcare CorporationNDACurrent
0338-1023PENICILLIN G POTASSIUMPENICILLIN GBaxter Healthcare CorporationNDACurrent
0338-1023PENICILLIN G POTASSIUMPENICILLIN GBaxter Healthcare CorporationNDACurrent
0338-1023PENICILLIN G POTASSIUMPENICILLIN GBaxter Healthcare CorporationNDACurrent
0338-1023PENICILLIN G POTASSIUMPENICILLIN GBaxter Healthcare CorporationNDACurrent
0338-1025PENICILLIN G POTASSIUMPENICILLIN GBaxter Healthcare CorporationNDACurrent
0338-1025PENICILLIN G POTASSIUMPENICILLIN GBaxter Healthcare CorporationNDACurrent
0338-1025PENICILLIN G POTASSIUMPENICILLIN GBaxter Healthcare CorporationNDACurrent
0338-1025PENICILLIN G POTASSIUMPENICILLIN GBaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76224SUPPL 2023-11-07
76219SUPPL 2023-11-03
50557SUPPL2017-12-01
50514SUPPL2017-11-28
17959SUPPL2016-07-21
30206SUPPL2016-07-20
7914SUPPL2012-04-18
17958SUPPL2012-04-16
39062SUPPL2008-03-05
30205SUPPL2008-03-05
30204SUPPL2005-02-08
30203SUPPL2004-06-15
30202SUPPL2002-08-23