Application 202383

Type
ANDA
Sponsor
DR REDDYS LABS LTD

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;ORAL300MGNoNo
006LAMOTRIGINELAMOTRIGINETABLET, EXTENDED RELEASE;ORAL250MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A202383-001LAMOTRIGINELAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-06-19
A202383-002LAMOTRIGINELAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-06-19
A202383-003LAMOTRIGINELAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-06-19
A202383-004LAMOTRIGINELAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-06-19
A202383-005LAMOTRIGINELAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2013-06-19
A202383-006LAMOTRIGINELAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORALAB2018-09-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A202383-001AB
A202383-002AB
A202383-003AB
A202383-004AB
A202383-005AB
A202383-006AB

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 · 242 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202383-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-06-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202383-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-06-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202383-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-06-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202383-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-06-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202383-005LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2013-06-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202383-006LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORALAB2018-09-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202383-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-06-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202383-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-06-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202383-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-06-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202383-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-06-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202383-005LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2013-06-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202383-006LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORALAB2018-09-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A202383-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-06-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202383-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-06-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202383-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-06-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202383-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-06-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202383-005LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2013-06-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202383-006LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORALAB2018-09-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202383-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-06-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202383-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-06-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202383-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-06-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202383-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-06-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202383-005LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2013-06-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202383-006LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORALAB2018-09-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202383-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-06-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202383-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-06-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202383-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-06-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202383-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-06-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202383-005LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2013-06-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202383-006LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORALAB2018-09-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202383-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-06-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202383-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-06-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202383-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-06-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202383-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-06-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202383-005LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2013-06-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202383-006LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORALAB2018-09-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202383-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-06-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202383-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-06-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202383-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-06-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202383-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-06-192680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 242 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202383-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202383-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202383-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202383-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202383-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202383-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202383-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202383-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202383-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202383-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202383-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202383-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202383-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202383-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202383-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202383-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202383-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202383-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202383-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202383-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202383-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202383-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202383-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202383-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202383-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202383-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202383-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202383-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202383-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202383-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202383-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202383-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202383-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202383-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202383-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202383-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202383-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202383-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202383-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202383-004AB12680178bc6a6…

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 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LamotrigineLAMOTRIGINEREMEDYREPACK INC.260dc37d-6e64-4688-82dc-10a1a428af172026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202383
application number: ANDA202383
LamotrigineLAMOTRIGINEDr.Reddy's Laboratories Limiteda69542ea-5b6f-15c1-9e7a-90ac839971d32025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202383
application number: ANDA202383
ndc (product): 55111-428
ndc (product): 55111-717
ndc (product): 55111-718
ndc (product): 55111-720
ndc (product): 55111-419
ndc (product): 55111-719
LamotrigineLAMOTRIGINENorthStar Rx LLC9ab07d6b-ae4a-a310-5572-b266676cd29e2025-11-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202383
application number: ANDA202383
ndc (product): 16714-625
ndc (product): 16714-624
ndc (product): 16714-626
ndc (product): 16714-893
ndc (product): 16714-627
ndc (product): 16714-623

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 61 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-623LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-623LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-623LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-623LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-624LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-624LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-624LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-624LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-625LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-625LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-625LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-625LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-626LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-626LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-626LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-626LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-627LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-627LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-627LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-627LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-893LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-893LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-893LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
16714-893LamotrigineLamotrigineNorthStar Rx LLCANDACurrent
55111-419LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
55111-419LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
55111-419LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
55111-419LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
55111-419LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
55111-428LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
55111-428LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
55111-428LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
55111-428LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
55111-428LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
55111-717LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
55111-717LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
55111-717LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
55111-717LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
55111-717LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
55111-718LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
55111-718LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
55111-718LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
55111-718LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
55111-718LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
55111-719LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
55111-719LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
55111-719LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
55111-719LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
55111-719LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
55111-720LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
55111-720LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
55111-720LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
55111-720LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
55111-720LamotrigineLamotrigineDr.Reddy's Laboratories LimitedANDACurrent
63629-8283LamotrigineLamotrigineBryant Ranch PrepackANDACurrent
63629-8283LamotrigineLamotrigineBryant Ranch PrepackANDACurrent
68788-6868LamotrigineLamotriginePreferred Pharmaceuticals Inc.ANDACurrent
68788-6868LamotrigineLamotriginePreferred Pharmaceuticals Inc.ANDACurrent
68788-6868LamotrigineLamotriginePreferred Pharmaceuticals Inc.ANDACurrent
68788-6868LamotrigineLamotriginePreferred Pharmaceuticals Inc.ANDACurrent
68788-6868LamotrigineLamotriginePreferred Pharmaceuticals Inc.ANDACurrent