FDA.reportPublic FDA data

Application 050138

Type
NDA
Sponsor
KING PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BICILLIN C-RPENICILLIN G BENZATHINE; PENICILLIN G PROCAINEINJECTABLE;INJECTION300,000 UNITS/ML;300,000 UNITS/MLYesYes
002BICILLIN C-RPENICILLIN G BENZATHINE; PENICILLIN G PROCAINEINJECTABLE;INJECTION150,000 UNITS/ML;150,000 UNITS/MLYesNo
003BICILLIN C-R 900/300PENICILLIN G BENZATHINE; PENICILLIN G PROCAINEINJECTABLE;INJECTION900,000 UNITS/2ML;300,000 UNITS/2MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-1815BICILLIN CRpenicillin G benzathine and penicillin G procaineA-S Medication SolutionsNDACurrent
60793-600BICILLIN CRpenicillin G benzathine and penicillin G procainePfizer Laboratories Div Pfizer IncNDACurrent
60793-600BICILLIN CRpenicillin G benzathine and penicillin G procainePfizer Laboratories Div Pfizer IncNDACurrent
60793-600BICILLIN CRpenicillin G benzathine and penicillin G procainePfizer Laboratories Div Pfizer IncNDACurrent
60793-600BICILLIN CRpenicillin G benzathine and penicillin G procainePfizer Laboratories Div Pfizer IncNDACurrent
60793-600BICILLIN CRpenicillin G benzathine and penicillin G procainePfizer Laboratories Div Pfizer IncNDACurrent
60793-600BICILLIN CRpenicillin G benzathine and penicillin G procainePfizer Laboratories Div Pfizer IncNDACurrent
60793-600BICILLIN CRpenicillin G benzathine and penicillin G procainePfizer Laboratories Div Pfizer IncNDACurrent
60793-601BICILLIN CRpenicillin G benzathine and penicillin G procainePfizer Laboratories Div Pfizer IncNDACurrent
60793-601BICILLIN CRpenicillin G benzathine and penicillin G procainePfizer Laboratories Div Pfizer IncNDACurrent
60793-601BICILLIN CRpenicillin G benzathine and penicillin G procainePfizer Laboratories Div Pfizer IncNDACurrent
60793-601BICILLIN CRpenicillin G benzathine and penicillin G procainePfizer Laboratories Div Pfizer IncNDACurrent
60793-601BICILLIN CRpenicillin G benzathine and penicillin G procainePfizer Laboratories Div Pfizer IncNDACurrent
60793-601BICILLIN CRpenicillin G benzathine and penicillin G procainePfizer Laboratories Div Pfizer IncNDACurrent
60793-601BICILLIN CRpenicillin G benzathine and penicillin G procainePfizer Laboratories Div Pfizer IncNDACurrent
60793-602BICILLIN C-R 900/300penicillin G benzathine and penicillin G procainePfizer Laboratories Div Pfizer IncNDACurrent
60793-602BICILLIN C-R 900/300penicillin G benzathine and penicillin G procainePfizer Laboratories Div Pfizer IncNDACurrent
60793-602BICILLIN C-R 900/300penicillin G benzathine and penicillin G procainePfizer Laboratories Div Pfizer IncNDACurrent
60793-602BICILLIN C-R 900/300penicillin G benzathine and penicillin G procainePfizer Laboratories Div Pfizer IncNDACurrent
60793-602BICILLIN C-R 900/300penicillin G benzathine and penicillin G procainePfizer Laboratories Div Pfizer IncNDACurrent
60793-602BICILLIN C-R 900/300penicillin G benzathine and penicillin G procainePfizer Laboratories Div Pfizer IncNDACurrent
60793-602BICILLIN C-R 900/300penicillin G benzathine and penicillin G procainePfizer Laboratories Div Pfizer IncNDACurrent
68258-8910BICILLIN CRpenicillin G benzathine and penicillin G procaineDispensing Solutions, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65583SUPPL2020-12-14
65575SUPPL2020-12-11
65560SUPPL2020-12-10
65535SUPPL2020-12-09
59855SUPPL2019-08-27
59850SUPPL2019-08-27
58505SUPPL2019-05-01
58488SUPPL2019-04-30
56463SUPPL2018-11-15
56316SUPPL2018-11-06
50657SUPPL2017-12-12
38915SUPPL2015-10-15
29988SUPPL2015-10-14
38914SUPPL2014-05-12
29987SUPPL2014-04-29
17802SUPPL2012-09-11
29986SUPPL2012-09-07
29985SUPPL2009-12-31
17801SUPPL2009-12-22
7695SUPPL2005-11-18
29984SUPPL2004-12-29
29982SUPPL2004-05-28
29983SUPPL2002-04-29
7694SUPPL2002-04-29