FDA.reportPublic FDA data

Application 078956

Type
ANDA
Sponsor
AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LAMOTRIGINELAMOTRIGINETABLET;ORAL25MGNoNo
002LAMOTRIGINELAMOTRIGINETABLET;ORAL100MGNoNo
003LAMOTRIGINELAMOTRIGINETABLET;ORAL150MGNoNo
004LAMOTRIGINELAMOTRIGINETABLET;ORAL200MGNoNo

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
A078956-001LAMOTRIGINELAMOTRIGINE25MGTABLET / ORALAB2009-01-27
A078956-002LAMOTRIGINELAMOTRIGINE100MGTABLET / ORALAB2009-01-27
A078956-003LAMOTRIGINELAMOTRIGINE150MGTABLET / ORALAB2009-01-27
A078956-004LAMOTRIGINELAMOTRIGINE200MGTABLET / ORALAB2009-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078956-001AB
A078956-002AB
A078956-003AB
A078956-004AB

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 UTC2026-02A078956-001LAMOTRIGINE25MGTABLET / ORALAB2009-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078956-002LAMOTRIGINE100MGTABLET / ORALAB2009-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078956-003LAMOTRIGINE150MGTABLET / ORALAB2009-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078956-004LAMOTRIGINE200MGTABLET / ORALAB2009-01-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078956-001LAMOTRIGINE25MGTABLET / ORALAB2009-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078956-002LAMOTRIGINE100MGTABLET / ORALAB2009-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078956-003LAMOTRIGINE150MGTABLET / ORALAB2009-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078956-004LAMOTRIGINE200MGTABLET / ORALAB2009-01-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078956-001LAMOTRIGINE25MGTABLET / ORALAB2009-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078956-002LAMOTRIGINE100MGTABLET / ORALAB2009-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078956-003LAMOTRIGINE150MGTABLET / ORALAB2009-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078956-004LAMOTRIGINE200MGTABLET / ORALAB2009-01-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078956-001LAMOTRIGINE25MGTABLET / ORALAB2009-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078956-002LAMOTRIGINE100MGTABLET / ORALAB2009-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078956-003LAMOTRIGINE150MGTABLET / ORALAB2009-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078956-004LAMOTRIGINE200MGTABLET / ORALAB2009-01-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078956-001LAMOTRIGINE25MGTABLET / ORALAB2009-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078956-002LAMOTRIGINE100MGTABLET / ORALAB2009-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078956-003LAMOTRIGINE150MGTABLET / ORALAB2009-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078956-004LAMOTRIGINE200MGTABLET / ORALAB2009-01-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078956-001LAMOTRIGINE25MGTABLET / ORALAB2009-01-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078956-002LAMOTRIGINE100MGTABLET / ORALAB2009-01-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078956-003LAMOTRIGINE150MGTABLET / ORALAB2009-01-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078956-004LAMOTRIGINE200MGTABLET / ORALAB2009-01-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078956-001LAMOTRIGINE25MGTABLET / ORALAB2009-01-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078956-002LAMOTRIGINE100MGTABLET / ORALAB2009-01-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078956-003LAMOTRIGINE150MGTABLET / ORALAB2009-01-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078956-004LAMOTRIGINE200MGTABLET / ORALAB2009-01-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078956-001LAMOTRIGINE25MGTABLET / ORALAB2009-01-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078956-002LAMOTRIGINE100MGTABLET / ORALAB2009-01-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078956-003LAMOTRIGINE150MGTABLET / ORALAB2009-01-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078956-004LAMOTRIGINE200MGTABLET / ORALAB2009-01-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078956-001LAMOTRIGINE25MGTABLET / ORALAB2009-01-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078956-002LAMOTRIGINE100MGTABLET / ORALAB2009-01-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078956-003LAMOTRIGINE150MGTABLET / ORALAB2009-01-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078956-004LAMOTRIGINE200MGTABLET / ORALAB2009-01-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078956-001LAMOTRIGINE25MGTABLET / ORALAB2009-01-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A078956-002LAMOTRIGINE100MGTABLET / ORALAB2009-01-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A078956-003LAMOTRIGINE150MGTABLET / ORALAB2009-01-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A078956-004LAMOTRIGINE200MGTABLET / ORALAB2009-01-27d06236e962d9…

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 UTC2026-02A078956-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078956-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078956-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078956-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078956-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078956-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078956-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078956-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078956-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078956-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078956-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078956-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078956-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078956-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078956-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078956-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078956-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078956-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078956-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078956-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078956-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078956-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078956-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078956-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078956-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078956-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078956-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078956-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078956-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078956-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078956-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078956-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078956-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078956-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078956-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078956-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078956-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078956-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078956-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078956-004AB1d06236e962d9…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LamotrigineLAMOTRIGINEREMEDYREPACK INC.6ef17301-6c0b-4941-a84d-12243875d2e22026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078956
application number: ANDA078956
ndc (product): 70518-3043
LamotrigineLAMOTRIGINEAurobindo Pharma Limiteda9a4309e-fe43-4a26-a30f-c6577d6503362026-05-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078956
application number: ANDA078956
ndc (product): 65862-229
ndc (product): 65862-228
ndc (product): 65862-227
ndc (product): 65862-230
LamotrigineLAMOTRIGINECoupler LLC3dfdcc2d-b7c5-7abf-e063-6394a90a24a62025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078956
application number: ANDA078956

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 65 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-700LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-700LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-700LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-700LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-700LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-700LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-700LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-701LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-701LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-701LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-701LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-701LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-701LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-701LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-702LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-702LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-702LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-702LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-702LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-702LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-702LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-703LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-703LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-703LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-703LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-703LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-703LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-703LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
50090-3129LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
65862-227LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-227LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-227LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-227LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-227LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-227LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-227LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-227LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-228LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-228LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-228LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-228LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-228LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-228LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-228LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-228LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-229LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-229LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-229LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-229LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-229LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-229LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-229LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-229LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-230LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-230LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-230LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-230LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-230LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-230LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-230LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-230LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
70518-3043LamotrigineLamotrigineREMEDYREPACK INC.ANDACurrent
70518-3109LamotrigineLamotrigineREMEDYREPACK INC.ANDACurrent
70518-3109LamotrigineLamotrigineREMEDYREPACK INC.ANDACurrent
70518-3139LamotrigineLamotrigineREMEDYREPACK INC.ANDACurrent