Application 206382

Type
ANDA
Sponsor
SCIEGEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LAMOTRIGINELAMOTRIGINETABLET, ORALLY DISINTEGRATING;ORAL25MGNoNo
002LAMOTRIGINELAMOTRIGINETABLET, ORALLY DISINTEGRATING;ORAL50MGNoNo
003LAMOTRIGINELAMOTRIGINETABLET, ORALLY DISINTEGRATING;ORAL100MGNoNo
004LAMOTRIGINELAMOTRIGINETABLET, ORALLY DISINTEGRATING;ORAL200MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A206382-001LAMOTRIGINELAMOTRIGINE25MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-17
A206382-002LAMOTRIGINELAMOTRIGINE50MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-17
A206382-003LAMOTRIGINELAMOTRIGINE100MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-17
A206382-004LAMOTRIGINELAMOTRIGINE200MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206382-001AB
A206382-002AB
A206382-003AB
A206382-004AB

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A206382-001LAMOTRIGINE25MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-1784e616aacf4f…
2026-09-14 22:38:342026-08A206382-002LAMOTRIGINE50MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-1784e616aacf4f…
2026-09-14 22:38:342026-08A206382-003LAMOTRIGINE100MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-1784e616aacf4f…
2026-09-14 22:38:342026-08A206382-004LAMOTRIGINE200MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-1784e616aacf4f…
2026-08-18 06:07:402026-07A206382-001LAMOTRIGINE25MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-17caaa826d4ba7…
2026-08-18 06:07:402026-07A206382-002LAMOTRIGINE50MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-17caaa826d4ba7…
2026-08-18 06:07:402026-07A206382-003LAMOTRIGINE100MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-17caaa826d4ba7…
2026-08-18 06:07:402026-07A206382-004LAMOTRIGINE200MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206382-001LAMOTRIGINE25MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206382-002LAMOTRIGINE50MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206382-003LAMOTRIGINE100MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206382-004LAMOTRIGINE200MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206382-001LAMOTRIGINE25MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206382-002LAMOTRIGINE50MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206382-003LAMOTRIGINE100MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206382-004LAMOTRIGINE200MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A206382-001LAMOTRIGINE25MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206382-002LAMOTRIGINE50MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206382-003LAMOTRIGINE100MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206382-004LAMOTRIGINE200MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206382-001LAMOTRIGINE25MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206382-002LAMOTRIGINE50MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206382-003LAMOTRIGINE100MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206382-004LAMOTRIGINE200MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206382-001LAMOTRIGINE25MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206382-002LAMOTRIGINE50MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206382-003LAMOTRIGINE100MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206382-004LAMOTRIGINE200MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206382-001LAMOTRIGINE25MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206382-002LAMOTRIGINE50MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206382-003LAMOTRIGINE100MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206382-004LAMOTRIGINE200MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206382-001LAMOTRIGINE25MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206382-002LAMOTRIGINE50MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206382-003LAMOTRIGINE100MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206382-004LAMOTRIGINE200MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206382-001LAMOTRIGINE25MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206382-002LAMOTRIGINE50MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206382-003LAMOTRIGINE100MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206382-004LAMOTRIGINE200MGTABLET, ORALLY DISINTEGRATING / ORALAB2016-06-175bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A206382-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A206382-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A206382-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A206382-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A206382-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206382-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206382-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206382-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206382-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206382-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206382-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206382-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206382-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206382-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206382-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206382-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206382-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206382-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206382-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206382-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206382-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206382-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206382-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206382-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206382-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206382-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206382-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206382-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206382-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206382-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206382-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206382-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206382-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206382-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206382-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206382-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206382-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206382-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206382-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206382-004AB15bbf6a4d5a75…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LamotrigineLAMOTRIGINEDr. Reddys Laboratories Inc.54ea1ec3-876b-4d3a-a92b-1a6d70951de02026-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206382
application number: ANDA206382
ndc (product): 43598-552
ndc (product): 43598-551
ndc (product): 43598-553
ndc (product): 43598-550
LamotrigineLAMOTRIGINEScieGen Pharmaceuticals, Inc.de700ac1-4048-467e-abb1-238953261a972022-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206382
application number: ANDA206382
ndc (product): 50228-322
ndc (product): 50228-319
ndc (product): 50228-320
ndc (product): 50228-321

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 · 64 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-550LamotrigineLamotrigineDr. ReddyANDACurrent
43598-550LamotrigineLamotrigineDr. ReddyANDACurrent
43598-550LamotrigineLamotrigineDr. ReddyANDACurrent
43598-550LamotrigineLamotrigineDr. ReddyANDACurrent
43598-550LamotrigineLamotrigineDr. ReddyANDACurrent
43598-550LamotrigineLamotrigineDr. ReddyANDACurrent
43598-551LamotrigineLamotrigineDr. ReddyANDACurrent
43598-551LamotrigineLamotrigineDr. ReddyANDACurrent
43598-551LamotrigineLamotrigineDr. ReddyANDACurrent
43598-551LamotrigineLamotrigineDr. ReddyANDACurrent
43598-551LamotrigineLamotrigineDr. ReddyANDACurrent
43598-551LamotrigineLamotrigineDr. ReddyANDACurrent
43598-552LamotrigineLamotrigineDr. ReddyANDACurrent
43598-552LamotrigineLamotrigineDr. ReddyANDACurrent
43598-552LamotrigineLamotrigineDr. ReddyANDACurrent
43598-552LamotrigineLamotrigineDr. ReddyANDACurrent
43598-552LamotrigineLamotrigineDr. ReddyANDACurrent
43598-552LamotrigineLamotrigineDr. ReddyANDACurrent
43598-553LamotrigineLamotrigineDr. ReddyANDACurrent
43598-553LamotrigineLamotrigineDr. ReddyANDACurrent
43598-553LamotrigineLamotrigineDr. ReddyANDACurrent
43598-553LamotrigineLamotrigineDr. ReddyANDACurrent
43598-553LamotrigineLamotrigineDr. ReddyANDACurrent
43598-553LamotrigineLamotrigineDr. ReddyANDACurrent
50228-319LamotrigineLamotrigineScieGen Pharmaceuticals, Inc.ANDACurrent
50228-319LamotrigineLamotrigineScieGen Pharmaceuticals, Inc.ANDACurrent
50228-319LamotrigineLamotrigineScieGen Pharmaceuticals, Inc.ANDACurrent
50228-319LamotrigineLamotrigineScieGen Pharmaceuticals, Inc.ANDACurrent
50228-319LamotrigineLamotrigineScieGen Pharmaceuticals, Inc.ANDACurrent
50228-319LamotrigineLamotrigineScieGen Pharmaceuticals, Inc.ANDACurrent
50228-320LamotrigineLamotrigineScieGen Pharmaceuticals, Inc.ANDACurrent
50228-320LamotrigineLamotrigineScieGen Pharmaceuticals, Inc.ANDACurrent
50228-320LamotrigineLamotrigineScieGen Pharmaceuticals, Inc.ANDACurrent
50228-320LamotrigineLamotrigineScieGen Pharmaceuticals, Inc.ANDACurrent
50228-320LamotrigineLamotrigineScieGen Pharmaceuticals, Inc.ANDACurrent
50228-320LamotrigineLamotrigineScieGen Pharmaceuticals, Inc.ANDACurrent
50228-321LamotrigineLamotrigineScieGen Pharmaceuticals, Inc.ANDACurrent
50228-321LamotrigineLamotrigineScieGen Pharmaceuticals, Inc.ANDACurrent
50228-321LamotrigineLamotrigineScieGen Pharmaceuticals, Inc.ANDACurrent
50228-321LamotrigineLamotrigineScieGen Pharmaceuticals, Inc.ANDACurrent
50228-321LamotrigineLamotrigineScieGen Pharmaceuticals, Inc.ANDACurrent
50228-321LamotrigineLamotrigineScieGen Pharmaceuticals, Inc.ANDACurrent
50228-322LamotrigineLamotrigineScieGen Pharmaceuticals, Inc.ANDACurrent
50228-322LamotrigineLamotrigineScieGen Pharmaceuticals, Inc.ANDACurrent
50228-322LamotrigineLamotrigineScieGen Pharmaceuticals, Inc.ANDACurrent
50228-322LamotrigineLamotrigineScieGen Pharmaceuticals, Inc.ANDACurrent
50228-322LamotrigineLamotrigineScieGen Pharmaceuticals, Inc.ANDACurrent
50228-322LamotrigineLamotrigineScieGen Pharmaceuticals, Inc.ANDACurrent
51407-060LamotrigineLamotrigineGolden State Medical Supply Inc.ANDACurrent
51407-060LamotrigineLamotrigineGolden State Medical Supply, Inc.ANDACurrent
51407-060LamotrigineLamotrigineGolden State Medical SupplyANDACurrent
51407-060LamotrigineLamotrigineGolden State Medical Supply, Inc.ANDACurrent
51407-061LamotrigineLamotrigineGolden State Medical Supply Inc.ANDACurrent
51407-061LamotrigineLamotrigineGolden State Medical Supply, Inc.ANDACurrent
51407-061LamotrigineLamotrigineGolden State Medical SupplyANDACurrent
51407-061LamotrigineLamotrigineGolden State Medical Supply, Inc.ANDACurrent
51407-062LamotrigineLamotrigineGolden State Medical Supply Inc.ANDACurrent
51407-062LamotrigineLamotrigineGolden State Medical Supply, Inc.ANDACurrent
51407-062LamotrigineLamotrigineGolden State Medical SupplyANDACurrent
51407-062LamotrigineLamotrigineGolden State Medical Supply, Inc.ANDACurrent
51407-063LamotrigineLamotrigineGolden State Medical Supply Inc.ANDACurrent
51407-063LamotrigineLamotrigineGolden State Medical Supply, Inc.ANDACurrent
51407-063LamotrigineLamotrigineGolden State Medical SupplyANDACurrent
51407-063LamotrigineLamotrigineGolden State Medical Supply, Inc.ANDACurrent