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 42.

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.

Product history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078106-001LEVETIRACETAM250MGTABLET / ORALAB2009-02-10caaa826d4ba7…
2026-08-18 06:07:402026-07A078106-002LEVETIRACETAM500MGTABLET / ORALAB2009-02-10caaa826d4ba7…
2026-08-18 06:07:402026-07A078106-003LEVETIRACETAM750MGTABLET / ORALAB2009-02-10caaa826d4ba7…
2026-08-18 06:07:402026-07A078106-004LEVETIRACETAM1GMTABLET / ORALAB2009-02-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078106-001LEVETIRACETAM250MGTABLET / ORALAB2009-02-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078106-002LEVETIRACETAM500MGTABLET / ORALAB2009-02-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078106-003LEVETIRACETAM750MGTABLET / ORALAB2009-02-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078106-004LEVETIRACETAM1GMTABLET / ORALAB2009-02-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078106-001LEVETIRACETAM250MGTABLET / ORALAB2009-02-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078106-002LEVETIRACETAM500MGTABLET / ORALAB2009-02-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078106-003LEVETIRACETAM750MGTABLET / ORALAB2009-02-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078106-004LEVETIRACETAM1GMTABLET / ORALAB2009-02-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A078106-001LEVETIRACETAM250MGTABLET / ORALAB2009-02-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078106-002LEVETIRACETAM500MGTABLET / ORALAB2009-02-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078106-003LEVETIRACETAM750MGTABLET / ORALAB2009-02-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078106-004LEVETIRACETAM1GMTABLET / ORALAB2009-02-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078106-001LEVETIRACETAM250MGTABLET / ORALAB2009-02-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078106-002LEVETIRACETAM500MGTABLET / ORALAB2009-02-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078106-003LEVETIRACETAM750MGTABLET / ORALAB2009-02-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078106-004LEVETIRACETAM1GMTABLET / ORALAB2009-02-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078106-001LEVETIRACETAM250MGTABLET / ORALAB2009-02-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078106-002LEVETIRACETAM500MGTABLET / ORALAB2009-02-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078106-003LEVETIRACETAM750MGTABLET / ORALAB2009-02-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078106-004LEVETIRACETAM1GMTABLET / ORALAB2009-02-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078106-001LEVETIRACETAM250MGTABLET / ORALAB2009-02-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078106-002LEVETIRACETAM500MGTABLET / ORALAB2009-02-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078106-003LEVETIRACETAM750MGTABLET / ORALAB2009-02-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078106-004LEVETIRACETAM1GMTABLET / ORALAB2009-02-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078106-001LEVETIRACETAM250MGTABLET / ORALAB2009-02-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078106-002LEVETIRACETAM500MGTABLET / ORALAB2009-02-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078106-003LEVETIRACETAM750MGTABLET / ORALAB2009-02-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078106-004LEVETIRACETAM1GMTABLET / ORALAB2009-02-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078106-001LEVETIRACETAM250MGTABLET / ORALAB2009-02-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078106-002LEVETIRACETAM500MGTABLET / ORALAB2009-02-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078106-003LEVETIRACETAM750MGTABLET / ORALAB2009-02-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078106-004LEVETIRACETAM1GMTABLET / ORALAB2009-02-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078106-001LEVETIRACETAM250MGTABLET / ORALAB2009-02-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078106-002LEVETIRACETAM500MGTABLET / ORALAB2009-02-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078106-003LEVETIRACETAM750MGTABLET / ORALAB2009-02-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078106-004LEVETIRACETAM1GMTABLET / ORALAB2009-02-10d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078106-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078106-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078106-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078106-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078106-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078106-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078106-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078106-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078106-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078106-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078106-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078106-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078106-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078106-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078106-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078106-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078106-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078106-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078106-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078106-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078106-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078106-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078106-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078106-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078106-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078106-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078106-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078106-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078106-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078106-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078106-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078106-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078106-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078106-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078106-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078106-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078106-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078106-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078106-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078106-004AB1d8e5a09893c0…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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