FDA.reportPublic FDA data

Application 060101

Type
ANDA
Sponsor
KING PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PENICILLIN G PROCAINEPENICILLIN G PROCAINEINJECTABLE;INJECTION600,000 UNITS/MLNoYes
002PENICILLIN G PROCAINEPENICILLIN G PROCAINEINJECTABLE;INJECTION300,000 UNITS/MLNoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A060101-001PENICILLIN G PROCAINEPENICILLIN G PROCAINE600,000 UNITS/MLINJECTABLE / INJECTIONRS, Approved before 1982
A060101-002PENICILLIN G PROCAINEPENICILLIN G PROCAINE300,000 UNITS/MLINJECTABLE / INJECTIONRS, Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A060101-001PENICILLIN G PROCAINE600,000 UNITS/MLINJECTABLE / INJECTIONRS, Approved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A060101-002PENICILLIN G PROCAINE300,000 UNITS/MLINJECTABLE / INJECTIONRS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A060101-001PENICILLIN G PROCAINE600,000 UNITS/MLINJECTABLE / INJECTIONRS, Approved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09A060101-002PENICILLIN G PROCAINE300,000 UNITS/MLINJECTABLE / INJECTIONRS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A060101-001PENICILLIN G PROCAINE600,000 UNITS/MLINJECTABLE / INJECTIONRS, Approved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A060101-002PENICILLIN G PROCAINE300,000 UNITS/MLINJECTABLE / INJECTIONRS, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A060101-001PENICILLIN G PROCAINE600,000 UNITS/MLINJECTABLE / INJECTIONRS, Approved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A060101-002PENICILLIN G PROCAINE300,000 UNITS/MLINJECTABLE / INJECTIONRS, Approved before 1982a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60793-130PENICILLIN G PROCAINEpenicillin g procainePfizer Laboratories Div Pfizer IncANDACurrent
60793-130PENICILLIN G PROCAINEpenicillin g procainePfizer Laboratories Div Pfizer IncANDACurrent
60793-130PENICILLIN G PROCAINEpenicillin g procainePfizer Laboratories Div Pfizer IncANDACurrent
60793-130PENICILLIN G PROCAINEpenicillin g procainePfizer Laboratories Div Pfizer IncANDACurrent
60793-130PENICILLIN G PROCAINEpenicillin g procainePfizer Laboratories Div Pfizer IncANDACurrent
60793-130PENICILLIN G PROCAINEpenicillin g procainePfizer Laboratories Div Pfizer IncANDACurrent
60793-130PENICILLIN G PROCAINEpenicillin g procainePfizer Laboratories Div Pfizer IncANDACurrent
60793-131PENICILLIN G PROCAINEpenicillin g procainePfizer Laboratories Div Pfizer IncANDACurrent
60793-131PENICILLIN G PROCAINEpenicillin g procainePfizer Laboratories Div Pfizer IncANDACurrent
60793-131PENICILLIN G PROCAINEpenicillin g procainePfizer Laboratories Div Pfizer IncANDACurrent
60793-131PENICILLIN G PROCAINEpenicillin g procainePfizer Laboratories Div Pfizer IncANDACurrent
60793-131PENICILLIN G PROCAINEpenicillin g procainePfizer Laboratories Div Pfizer IncANDACurrent
60793-131PENICILLIN G PROCAINEpenicillin g procainePfizer Laboratories Div Pfizer IncANDACurrent
60793-131PENICILLIN G PROCAINEpenicillin g procainePfizer Laboratories Div Pfizer IncANDACurrent