FDA.reportPublic FDA data

Application 078106

Type
ANDA
Sponsor
PRINSTON INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVETIRACETAMLEVETIRACETAMTABLET;ORAL250MGNoNo
002LEVETIRACETAMLEVETIRACETAMTABLET;ORAL500MGNoNo
003LEVETIRACETAMLEVETIRACETAMTABLET;ORAL750MGNoNo
004LEVETIRACETAMLEVETIRACETAMTABLET;ORAL1GMNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078106-001LEVETIRACETAMLEVETIRACETAM250MGTABLET / ORALAB2009-02-10
A078106-002LEVETIRACETAMLEVETIRACETAM500MGTABLET / ORALAB2009-02-10
A078106-003LEVETIRACETAMLEVETIRACETAM750MGTABLET / ORALAB2009-02-10
A078106-004LEVETIRACETAMLEVETIRACETAM1GMTABLET / ORALAB2009-02-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A078106-001AB
A078106-002AB
A078106-003AB
A078106-004AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A078106-001LEVETIRACETAM250MGTABLET / ORALAB2009-02-10a50c72e98297…
2026-08-01 22:54:322026-06A078106-002LEVETIRACETAM500MGTABLET / ORALAB2009-02-10a50c72e98297…
2026-08-01 22:54:322026-06A078106-003LEVETIRACETAM750MGTABLET / ORALAB2009-02-10a50c72e98297…
2026-08-01 22:54:322026-06A078106-004LEVETIRACETAM1GMTABLET / ORALAB2009-02-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078106-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A078106-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A078106-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A078106-004AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevetiracetamLEVETIRACETAMBryant Ranch Prepacked8e88d0-993e-4683-bdcf-31578130d3df2024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078106
application number: ANDA078106
ndc (product): 63629-7516
LevetiracetamLEVETIRACETAMSolco Healthcare US, LLC57f09129-7151-4a75-9d73-9dd32f74ba432024-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078106
application number: ANDA078106
LevetiracetamLEVETIRACETAMSolco Healthcare US, LLCdd713e60-478c-43cd-b680-ff594a0b38642024-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078106
application number: ANDA078106
ndc (product): 43547-222
ndc (product): 43547-221
ndc (product): 43547-223
ndc (product): 43547-224
LevetiracetamLEVETIRACETAMPrinston Pharmaceutical Inc.d818ef84-9b3e-434b-92d9-910cfa8af7da2020-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078106
application number: ANDA078106
ndc (product): 76494-530
ndc (product): 76494-531
ndc (product): 76494-529
ndc (product): 76494-528

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 69 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43547-221LevetiracetamLevetiracetamSolco Healthcare US, LLCANDACurrent
43547-221LevetiracetamLevetiracetamSolco Healthcare US, LLCANDACurrent
43547-221LevetiracetamLevetiracetamSolco Healthcare US, LLCANDACurrent
43547-221LevetiracetamLevetiracetamSolco Healthcare US, LLCANDACurrent
43547-222LevetiracetamLevetiracetamSolco Healthcare US, LLCANDACurrent
43547-222LevetiracetamLevetiracetamSolco Healthcare US, LLCANDACurrent
43547-222LevetiracetamLevetiracetamSolco Healthcare US, LLCANDACurrent
43547-222LevetiracetamLevetiracetamSolco Healthcare US, LLCANDACurrent
43547-223LevetiracetamLevetiracetamSolco Healthcare US, LLCANDACurrent
43547-223LevetiracetamLevetiracetamSolco Healthcare US, LLCANDACurrent
43547-223LevetiracetamLevetiracetamSolco Healthcare US, LLCANDACurrent
43547-223LevetiracetamLevetiracetamSolco Healthcare US, LLCANDACurrent
43547-224LevetiracetamLevetiracetamSolco Healthcare US, LLCANDACurrent
43547-224LevetiracetamLevetiracetamSolco Healthcare US, LLCANDACurrent
43547-224LevetiracetamLevetiracetamSolco Healthcare US, LLCANDACurrent
43547-224LevetiracetamLevetiracetamSolco Healthcare US, LLCANDACurrent
50090-2134LevetiracetamLevetiracetamA-S Medication SolutionsANDACurrent
50090-3518LevetiracetamLevetiracetamA-S Medication SolutionsANDACurrent
50090-3518LevetiracetamLevetiracetamA-S Medication SolutionsANDACurrent
50090-3518LevetiracetamLevetiracetamA-S Medication SolutionsANDACurrent
50268-472LevetiracetamLevetiracetamAvPAKANDACurrent
50268-472LevetiracetamLevetiracetamAvPAKANDACurrent
50268-473LevetiracetamLevetiracetamAvPAKANDACurrent
50268-473LevetiracetamLevetiracetamAvPAKANDACurrent
50268-474LevetiracetamLevetiracetamAvPAKANDACurrent
50268-474LevetiracetamLevetiracetamAvPAKANDACurrent
50268-475LevetiracetamLevetiracetamAvPAKANDACurrent
50268-475LevetiracetamLevetiracetamAvPAKANDACurrent
61919-552LEVETIRACETAMLEVETIRACETAMDIRECT RXANDACurrent
61919-552LEVETIRACETAMLEVETIRACETAMDIRECT RXANDACurrent
61919-552LEVETIRACETAMLEVETIRACETAMDirect_RxANDACurrent
61919-552LEVETIRACETAMLEVETIRACETAMDirect_RxANDACurrent
61919-559LEVETIRACETAMLEVETIRACETAMDIRECT RXANDACurrent
61919-559LEVETIRACETAMLEVETIRACETAMDirect_RxANDACurrent
61919-559LEVETIRACETAMLEVETIRACETAMDirect_RxANDACurrent
63629-7516LevetiracetamLevetiracetamBryant Ranch PrepackANDACurrent
63629-7516LevetiracetamLevetiracetamBryant Ranch PrepackANDACurrent
63629-7516LevetiracetamLevetiracetamBryant Ranch PrepackANDACurrent
67296-1248LevetiracetamLevetiracetamRedPharm Drug, Inc.ANDACurrent
67296-1248LevetiracetamLevetiracetamRedPharm Drug, Inc.ANDACurrent
67296-1248LevetiracetamLevetiracetamRedPharm Drug, Inc.ANDACurrent
68071-4508LevetiracetamLevetiracetamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4508LevetiracetamLevetiracetamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4508LevetiracetamLevetiracetamNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7074LevetiracetamLevetiracetamPreferred Pharmaceuticals Inc.ANDACurrent
68788-7074LevetiracetamLevetiracetamPreferred Pharmaceuticals Inc.ANDACurrent
68788-7074LevetiracetamLevetiracetamPreferred Pharmaceuticals Inc.ANDACurrent
68788-7074LevetiracetamLevetiracetamPreferred Pharmaceuticals Inc.ANDACurrent
68788-7534LevetiracetamLevetiracetamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7534LevetiracetamLevetiracetamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7534LevetiracetamLevetiracetamPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0365LevetiracetamLevetiracetamREMEDYREPACK INC.ANDACurrent
70518-0943LevetiracetamLevetiracetamREMEDYREPACK INC.ANDACurrent
70518-0943LevetiracetamLevetiracetamREMEDYREPACK INC.ANDACurrent
70518-1123LevetiracetamLevetiracetamREMEDYREPACK INC.ANDACurrent
70518-1123LevetiracetamLevetiracetamREMEDYREPACK INC.ANDACurrent
70518-1623LevetiracetamLevetiracetamREMEDYREPACK INC.ANDACurrent
70518-1623LevetiracetamLevetiracetamREMEDYREPACK INC.ANDACurrent
71335-0748LevetiracetamLevetiracetamBryant Ranch PrepackANDACurrent
71335-0748LevetiracetamLevetiracetamBryant Ranch PrepackANDACurrent
71335-0748LevetiracetamLevetiracetamBryant Ranch PrepackANDACurrent
76494-528LevetiracetamLevetiracetamPrinston Pharmaceutical Inc.ANDACurrent
76494-528LevetiracetamLevetiracetamPrinston Pharmaceutical Inc.ANDACurrent
76494-529LevetiracetamLevetiracetamPrinston Pharmaceutical Inc.ANDACurrent
76494-529LevetiracetamLevetiracetamPrinston Pharmaceutical Inc.ANDACurrent
76494-530LevetiracetamLevetiracetamPrinston Pharmaceutical Inc.ANDACurrent
76494-530LevetiracetamLevetiracetamPrinston Pharmaceutical Inc.ANDACurrent
76494-531LevetiracetamLevetiracetamPrinston Pharmaceutical Inc.ANDACurrent
76494-531LevetiracetamLevetiracetamPrinston Pharmaceutical Inc.ANDACurrent