FDA.reportPublic FDA data

Application 050141

Type
NDA
Sponsor
KING PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BICILLIN L-APENICILLIN G BENZATHINEINJECTABLE;INJECTION600,000 UNITS/MLYesYes
003BICILLIN L-APENICILLIN G BENZATHINEINJECTABLE;INJECTION300,000 UNITS/MLYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-1016BICILLIN L-Apenicillin G benzathineA-S Medication SolutionsNDACurrent
50090-1016BICILLIN L-Apenicillin G benzathineA-S Medication SolutionsNDACurrent
50090-1016BICILLIN L-Apenicillin G benzathineA-S Medication SolutionsNDACurrent
50090-1016BICILLIN L-Apenicillin G benzathineA-S Medication SolutionsNDACurrent
50090-1016BICILLIN L-Apenicillin G benzathineA-S Medication SolutionsNDACurrent
50090-1666BICILLIN L-Apenicillin G benzathineA-S Medication SolutionsNDACurrent
50090-1666BICILLIN L-Apenicillin G benzathineA-S Medication SolutionsNDACurrent
50090-1666BICILLIN L-Apenicillin G benzathineA-S Medication SolutionsNDACurrent
60793-700BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
60793-700BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
60793-700BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
60793-700BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
60793-700BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
60793-700BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
60793-700BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
60793-700BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
60793-700BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
60793-700BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
60793-701BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
60793-701BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
60793-701BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
60793-701BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
60793-701BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
60793-701BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
60793-701BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
60793-701BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
60793-701BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
60793-701BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
60793-702BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
60793-702BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
60793-702BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
60793-702BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
60793-702BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
60793-702BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
60793-702BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
60793-702BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
60793-702BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
60793-702BICILLIN L-Apenicillin G benzathinePfizer Laboratories Div Pfizer IncNDACurrent
68071-1824BICILLIN L-Apenicillin G benzathineNuCare Pharmaceuticals,Inc.NDACurrent
68071-1824BICILLIN L-Apenicillin G benzathineNuCare Pharmaceuticals,Inc.NDACurrent
68071-1824BICILLIN L-Apenicillin G benzathineNuCare Pharmaceuticals,Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67533SUPPL2021-05-18
67508SUPPL2021-05-17
65584SUPPL2020-12-14
65576SUPPL2020-12-11
65561SUPPL2020-12-10
65536SUPPL2020-12-09
58506SUPPL2019-05-03
58489SUPPL2019-04-30
56464SUPPL2018-11-15
56392SUPPL2018-11-08
50658SUPPL2017-12-12
17803SUPPL2015-10-15
29990SUPPL2015-10-14
38918SUPPL2014-05-12
29989SUPPL2014-04-29
38917SUPPL2012-09-11
7701SUPPL2012-09-07
7700SUPPL2009-12-31
38916SUPPL2009-12-22
7699SUPPL2005-11-18
7698SUPPL2002-04-29
7697SUPPL2002-04-29
7696SUPPL2002-03-01