Application 201791

Type
ANDA
Sponsor
PAR PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LAMOTRIGINELAMOTRIGINETABLET, EXTENDED RELEASE;ORAL25MGNoNo
002LAMOTRIGINELAMOTRIGINETABLET, EXTENDED RELEASE;ORAL50MGNoNo
003LAMOTRIGINELAMOTRIGINETABLET, EXTENDED RELEASE;ORAL100MGNoNo
004LAMOTRIGINELAMOTRIGINETABLET, EXTENDED RELEASE;ORAL200MGNoNo
005LAMOTRIGINELAMOTRIGINETABLET, EXTENDED RELEASE;ORAL250MGNoNo
006LAMOTRIGINELAMOTRIGINETABLET, EXTENDED RELEASE;ORAL300MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201791-001LAMOTRIGINELAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORAL2013-01-18
A201791-002LAMOTRIGINELAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORAL2013-01-18
A201791-003LAMOTRIGINELAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORAL2013-01-18
A201791-004LAMOTRIGINELAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORAL2013-01-18
A201791-005LAMOTRIGINELAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORAL2013-01-18
A201791-006LAMOTRIGINELAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORAL2013-01-18

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 7 · 264 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A201791-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORAL2013-01-18c2088c7a36db…
2026-10-15 13:18:302026-09A201791-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORAL2013-01-18c2088c7a36db…
2026-10-15 13:18:302026-09A201791-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORAL2013-01-18c2088c7a36db…
2026-10-15 13:18:302026-09A201791-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORAL2013-01-18c2088c7a36db…
2026-10-15 13:18:302026-09A201791-005LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORAL2013-01-18c2088c7a36db…
2026-10-15 13:18:302026-09A201791-006LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORAL2013-01-18c2088c7a36db…
2026-09-14 22:38:342026-08A201791-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORAL2013-01-1884e616aacf4f…
2026-09-14 22:38:342026-08A201791-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORAL2013-01-1884e616aacf4f…
2026-09-14 22:38:342026-08A201791-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORAL2013-01-1884e616aacf4f…
2026-09-14 22:38:342026-08A201791-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORAL2013-01-1884e616aacf4f…
2026-09-14 22:38:342026-08A201791-005LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORAL2013-01-1884e616aacf4f…
2026-09-14 22:38:342026-08A201791-006LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORAL2013-01-1884e616aacf4f…
2026-08-18 06:07:402026-07A201791-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORAL2013-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07A201791-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORAL2013-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07A201791-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORAL2013-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07A201791-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORAL2013-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07A201791-005LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORAL2013-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07A201791-006LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORAL2013-01-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201791-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201791-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201791-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201791-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201791-005LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORALAB2013-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201791-006LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2013-01-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201791-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201791-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201791-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201791-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201791-005LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORALAB2013-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201791-006LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2013-01-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A201791-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201791-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201791-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201791-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201791-005LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORALAB2013-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201791-006LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2013-01-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201791-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201791-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201791-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201791-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-01-18fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 240 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A201791-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201791-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201791-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201791-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201791-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201791-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201791-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201791-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201791-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201791-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201791-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201791-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201791-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201791-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201791-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201791-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201791-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201791-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201791-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201791-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201791-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201791-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201791-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201791-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201791-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201791-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201791-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201791-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201791-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201791-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201791-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201791-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201791-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201791-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201791-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201791-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201791-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201791-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201791-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201791-004AB12680178bc6a6…

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 5 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LamotrigineLAMOTRIGINENuCare Pharmaceuticals,Inc.065e97c9-3c5f-16e6-e063-6294a90a13fc2025-01-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LAMOTRIGINELAMOTRIGINEDIRECT RXa835b697-2beb-1ba8-e053-2995a90a470c2025-01-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LAMOTRIGINE
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEAdvanced Rx Pharmacy of Tennessee, LLCf7a86237-ece4-7cc4-e053-6294a90a13082024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEDr.Reddy's Laboratories Limited44670496-41ea-36a1-c435-32e359766a742024-12-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTIRIGINEZydus Lifesciences Limitedecb7a528-699f-4e51-9887-dee60456da2f2024-11-30Name fallback
brand name: Lamotrigine
LamotrigineLAMOTRIGINEAlembic Pharmaceuticals Limitedfaee013c-cad2-4abb-904c-e6ff79ba778c2024-10-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINENCS HealthCare of KY, LLC dba Vangard Labse243e803-e95f-47a6-a6da-5fed657f44622024-08-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LAMOTRIGINELAMOTRIGINENuCare Pharmaceuticals,Inc.1bbbe2a2-a9e8-8c13-e063-6394a90a96272024-06-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LAMOTRIGINE
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEBryant Ranch Prepack36f383af-8b71-4875-85ef-3a7a8b1d88052024-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEProficient Rx LPffa46cb2-16e7-45f3-9940-5cb88d0cda9d2024-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEProficient Rx LP6f7e59d2-4311-42a0-93a0-b29b0417d96f2024-02-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEA-S Medication Solutions5a9575bb-230e-46ae-b58e-41554bad45eb2023-11-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
lamotrigineLAMOTRIGINE EXTENDED-RELEASEProficient Rx LP39efe933-bfed-4a6a-b270-0883871c51862023-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: lamotrigine
LAMOTRIGINELAMOTRIGINEA-S Medication Solutions4e6cc1ad-55cd-4c7f-878c-fa6716e958972023-04-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LAMOTRIGINE
generic name: LAMOTRIGINE
lamotrigineLAMOTRIGINE CHEWABLE DISPERSIBLEAlembic Pharmaceuticals Limitedae6522d4-d824-44aa-afe0-70cdcbd845af2023-01-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: lamotrigine
LamotrigineLAMOTRIGINEAscend Laboratories, LLC70cd448a-2921-4c69-bdf2-5a6ce883bd072022-12-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEScieGen Pharmaceuticals, Inc.de700ac1-4048-467e-abb1-238953261a972022-11-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEProficient Rx LP52273d60-3f27-4846-bf40-014ebcf094172022-05-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEProficient Rx LPb94ae2e4-e276-40c1-bc25-da980194fc992022-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEAsclemed USA, Inc.8ac9dc83-edb2-4ae5-8064-40f113fd3aab2020-10-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE

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 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49884-561Lamotrigine Extended Releaselamotrigine extended releasePar Pharmaceutical, Inc.ANDACurrent
49884-561Lamotrigine Extended Releaselamotrigine extended releasePar Pharmaceutical, Inc.ANDACurrent
49884-561Lamotrigine Extended Releaselamotrigine extended releasePar Pharmaceutical, Inc.ANDACurrent
49884-562Lamotrigine Extended Releaselamotrigine extended releasePar Pharmaceutical, Inc.ANDACurrent
49884-562Lamotrigine Extended Releaselamotrigine extended releasePar Pharmaceutical, Inc.ANDACurrent
49884-562Lamotrigine Extended Releaselamotrigine extended releasePar Pharmaceutical, Inc.ANDACurrent
49884-563Lamotrigine Extended Releaselamotrigine extended releasePar Pharmaceutical, Inc.ANDACurrent
49884-563Lamotrigine Extended Releaselamotrigine extended releasePar Pharmaceutical, Inc.ANDACurrent
49884-563Lamotrigine Extended Releaselamotrigine extended releasePar Pharmaceutical, Inc.ANDACurrent
49884-564Lamotrigine Extended Releaselamotrigine extended releasePar Pharmaceutical, Inc.ANDACurrent
49884-564Lamotrigine Extended Releaselamotrigine extended releasePar Pharmaceutical, Inc.ANDACurrent
49884-564Lamotrigine Extended Releaselamotrigine extended releasePar Pharmaceutical, Inc.ANDACurrent
49884-604Lamotrigine Extended Releaselamotrigine extended releasePar Pharmaceutical, Inc.ANDACurrent
49884-604Lamotrigine Extended Releaselamotrigine extended releasePar Pharmaceutical, Inc.ANDACurrent
49884-604Lamotrigine Extended Releaselamotrigine extended releasePar Pharmaceutical, Inc.ANDACurrent
49884-605Lamotrigine Extended Releaselamotrigine extended releasePar Pharmaceutical, Inc.ANDACurrent
49884-605Lamotrigine Extended Releaselamotrigine extended releasePar Pharmaceutical, Inc.ANDACurrent
49884-605Lamotrigine Extended Releaselamotrigine extended releasePar Pharmaceutical, Inc.ANDACurrent
63629-7020Lamotrigine Extended Releaselamotrigine extended releaseBryant Ranch PrepackANDACurrent
63629-7020Lamotrigine Extended Releaselamotrigine extended releaseBryant Ranch PrepackANDACurrent
63629-7020Lamotrigine Extended Releaselamotrigine extended releaseBryant Ranch PrepackANDACurrent
70518-0489Lamotrigine Extended Releaselamotrigine extended releaseREMEDYREPACK INC.ANDACurrent
70518-0489Lamotrigine Extended Releaselamotrigine extended releaseREMEDYREPACK INC.ANDACurrent