FDA.reportPublic FDA data

Application 078858

Type
ANDA
Sponsor
TORRENT PHARMS

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
A078858-001LEVETIRACETAMLEVETIRACETAM250MGTABLET / ORALAB2009-01-15
A078858-002LEVETIRACETAMLEVETIRACETAM500MGTABLET / ORALAB2009-01-15
A078858-003LEVETIRACETAMLEVETIRACETAM750MGTABLET / ORALAB2009-01-15
A078858-004LEVETIRACETAMLEVETIRACETAM1GMTABLET / ORALAB2009-01-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078858-001AB
A078858-002AB
A078858-003AB
A078858-004AB

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078858-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078858-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078858-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078858-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078858-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078858-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078858-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078858-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078858-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078858-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078858-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078858-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078858-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078858-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078858-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078858-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078858-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078858-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078858-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078858-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078858-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078858-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078858-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078858-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078858-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078858-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078858-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078858-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078858-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078858-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078858-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078858-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078858-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078858-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078858-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078858-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078858-001LEVETIRACETAM250MGTABLET / ORALAB2009-01-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A078858-002LEVETIRACETAM500MGTABLET / ORALAB2009-01-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A078858-003LEVETIRACETAM750MGTABLET / ORALAB2009-01-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A078858-004LEVETIRACETAM1GMTABLET / ORALAB2009-01-15d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078858-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078858-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078858-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078858-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078858-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078858-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078858-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078858-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078858-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078858-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078858-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078858-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078858-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078858-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078858-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078858-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078858-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078858-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078858-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078858-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078858-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078858-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078858-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078858-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078858-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078858-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078858-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078858-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078858-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078858-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078858-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078858-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078858-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078858-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078858-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078858-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078858-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078858-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078858-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078858-004AB1d06236e962d9…

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
LevetiracetamLEVETIRACETAMOWP Pharmaceuticals, Inc.e662bf5b-c81c-4bcd-ba2e-552df95ca6f92025-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078858
application number: ANDA078858
ndc (product): 69102-108
ndc (product): 69102-107
ndc (product): 69102-105
ndc (product): 69102-106
LevetiracetamLEVETIRACETAMPD-Rx Pharmaceuticals, Inc.c2177034-e164-453c-be02-1cf91ce27a072025-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078858
application number: ANDA078858
ndc (product): 43063-499
LevetiracetamLEVETIRACETAMTorrent Pharmaceuticals Limited6ab24168-058d-496e-9023-da8ee6353eb32025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078858
application number: ANDA078858
ndc (product): 13668-016
ndc (product): 13668-014
ndc (product): 13668-017
ndc (product): 13668-015
LevetiracetamLEVETIRACETAMBryant Ranch Prepackb738377c-035e-4b2e-9909-0a8fe07aa0fb2024-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078858
application number: ANDA078858

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 76 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7684LevetiracetamLevetiracetamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-6051LevetiracetamLevetiracetamMajor PharmaceuticalsANDACurrent
0904-6051LevetiracetamLevetiracetamMajor PharmaceuticalsANDACurrent
0904-6051LevetiracetamLevetiracetamMajor PharmaceuticalsANDACurrent
0904-6051LevetiracetamLevetiracetamMajor PharmaceuticalsANDACurrent
0904-6051LevetiracetamLevetiracetamMajor PharmaceuticalsANDACurrent
0904-6052LevetiracetamLevetiracetamMajor PharmaceuticalsANDACurrent
0904-6052LevetiracetamLevetiracetamMajor PharmaceuticalsANDACurrent
0904-6052LevetiracetamLevetiracetamMajor PharmaceuticalsANDACurrent
0904-6052LevetiracetamLevetiracetamMajor PharmaceuticalsANDACurrent
0904-6052LevetiracetamLevetiracetamMajor PharmaceuticalsANDACurrent
0904-6053LevetiracetamLevetiracetamMajor PharmaceuticalsANDACurrent
0904-6053LevetiracetamLevetiracetamMajor PharmaceuticalsANDACurrent
0904-6053LevetiracetamLevetiracetamMajor PharmaceuticalsANDACurrent
0904-6053LevetiracetamLevetiracetamMajor PharmaceuticalsANDACurrent
0904-6053LevetiracetamLevetiracetamMajor PharmaceuticalsANDACurrent
13668-014LevetiracetamLevetiracetamTorrent Pharmaceuticals LimitedANDACurrent
13668-014LevetiracetamLevetiracetamTorrent Pharmaceuticals LimitedANDACurrent
13668-014LevetiracetamLevetiracetamTorrent Pharmaceuticals LimitedANDACurrent
13668-014LevetiracetamLevetiracetamTorrent Pharmaceuticals LimitedANDACurrent
13668-014LevetiracetamLevetiracetamTorrent Pharmaceuticals LimitedANDACurrent
13668-014LevetiracetamLevetiracetamTorrent Pharmaceuticals LimitedANDACurrent
13668-014LevetiracetamLevetiracetamTorrent Pharmaceuticals LimitedANDACurrent
13668-015LevetiracetamLevetiracetamTorrent Pharmaceuticals LimitedANDACurrent
13668-015LevetiracetamLevetiracetamTorrent Pharmaceuticals LimitedANDACurrent
13668-015LevetiracetamLevetiracetamTorrent Pharmaceuticals LimitedANDACurrent
13668-015LevetiracetamLevetiracetamTorrent Pharmaceuticals LimitedANDACurrent
13668-015LevetiracetamLevetiracetamTorrent Pharmaceuticals LimitedANDACurrent
13668-015LevetiracetamLevetiracetamTorrent Pharmaceuticals LimitedANDACurrent
13668-015LevetiracetamLevetiracetamTorrent Pharmaceuticals LimitedANDACurrent
13668-016LevetiracetamLevetiracetamTorrent Pharmaceuticals LimitedANDACurrent
13668-016LevetiracetamLevetiracetamTorrent Pharmaceuticals LimitedANDACurrent
13668-016LevetiracetamLevetiracetamTorrent Pharmaceuticals LimitedANDACurrent
13668-016LevetiracetamLevetiracetamTorrent Pharmaceuticals LimitedANDACurrent
13668-016LevetiracetamLevetiracetamTorrent Pharmaceuticals LimitedANDACurrent
13668-016LevetiracetamLevetiracetamTorrent Pharmaceuticals LimitedANDACurrent
13668-016LevetiracetamLevetiracetamTorrent Pharmaceuticals LimitedANDACurrent
13668-017LevetiracetamLevetiracetamTorrent Pharmaceuticals LimitedANDACurrent
13668-017LevetiracetamLevetiracetamTorrent Pharmaceuticals LimitedANDACurrent
13668-017LevetiracetamLevetiracetamTorrent Pharmaceuticals LimitedANDACurrent
13668-017LevetiracetamLevetiracetamTorrent Pharmaceuticals LimitedANDACurrent
13668-017LevetiracetamLevetiracetamTorrent Pharmaceuticals LimitedANDACurrent
13668-017LevetiracetamLevetiracetamTorrent Pharmaceuticals LimitedANDACurrent
13668-017LevetiracetamLevetiracetamTorrent Pharmaceuticals LimitedANDACurrent
21695-006LevetiracetamLevetiracetamRebel Distributors CorpANDACurrent
21695-016LevetiracetamLevetiracetamRebel Distributors CorpANDACurrent
21695-071LevetiracetamLevetiracetamRebel Distributors CorpANDACurrent
21695-136LevetiracetamLevetiracetamRebel Distributors CorpANDACurrent
43063-499LevetiracetamLevetiracetamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-499LevetiracetamLevetiracetamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-499LevetiracetamLevetiracetamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-499LevetiracetamLevetiracetamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-499LevetiracetamLevetiracetamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-499LevetiracetamLevetiracetamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-499LevetiracetamLevetiracetamPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-2815LevetiracetamLevetiracetamA-S Medication SolutionsANDACurrent
55154-7647LevetiracetamLevetiracetamCardinal HealthANDACurrent
55154-7647LevetiracetamLevetiracetamCardinal HealthANDACurrent
55154-7647LevetiracetamLevetiracetamCardinal HealthANDACurrent
55154-7647LevetiracetamLevetiracetamCardinal HealthANDACurrent
55154-7647LevetiracetamLevetiracetamCardinal HealthANDACurrent
55154-7647LevetiracetamLevetiracetamCardinal HealthANDACurrent
55154-7887LevetiracetamLevetiracetamCardinal HealthANDACurrent
55154-7887LevetiracetamLevetiracetamCardinal HealthANDACurrent
55154-7887LevetiracetamLevetiracetamCardinal HealthANDACurrent
55154-7887LevetiracetamLevetiracetamCardinal HealthANDACurrent
55154-7887LevetiracetamLevetiracetamCardinal HealthANDACurrent
69102-105LevetiracetamLevetiracetamOWP Pharmaceuticals, Inc.ANDACurrent
69102-105LevetiracetamLevetiracetamOWP Pharmaceuticals, Inc.ANDACurrent
69102-106LevetiracetamLevetiracetamOWP Pharmaceuticals, Inc.ANDACurrent
69102-106LevetiracetamLevetiracetamOWP Pharmaceuticals, Inc.ANDACurrent
69102-107LevetiracetamLevetiracetamOWP Pharmaceuticals, Inc.ANDACurrent
69102-107LevetiracetamLevetiracetamOWP Pharmaceuticals, Inc.ANDACurrent
69102-108RoweepraLevetiracetamOWP Pharmaceuticals, Inc.ANDACurrent
69102-108RoweepraLevetiracetamOWP Pharmaceuticals, Inc.ANDACurrent
70518-2298LevetiracetamLevetiracetamREMEDYREPACK INC.ANDACurrent