Application 090170

Type
ANDA
Sponsor
UNICHEM LABS LTD

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
A090170-001LAMOTRIGINELAMOTRIGINE25MGTABLET / ORALAB2011-10-06
A090170-002LAMOTRIGINELAMOTRIGINE100MGTABLET / ORALAB2011-10-06
A090170-003LAMOTRIGINELAMOTRIGINE150MGTABLET / ORALAB2011-10-06
A090170-004LAMOTRIGINELAMOTRIGINE200MGTABLET / ORALAB2011-10-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090170-001AB
A090170-002AB
A090170-003AB
A090170-004AB

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 UTC2026-02A090170-001LAMOTRIGINE25MGTABLET / ORALAB2011-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090170-002LAMOTRIGINE100MGTABLET / ORALAB2011-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090170-003LAMOTRIGINE150MGTABLET / ORALAB2011-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090170-004LAMOTRIGINE200MGTABLET / ORALAB2011-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090170-001LAMOTRIGINE25MGTABLET / ORALAB2011-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090170-002LAMOTRIGINE100MGTABLET / ORALAB2011-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090170-003LAMOTRIGINE150MGTABLET / ORALAB2011-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090170-004LAMOTRIGINE200MGTABLET / ORALAB2011-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090170-001LAMOTRIGINE25MGTABLET / ORALAB2011-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090170-002LAMOTRIGINE100MGTABLET / ORALAB2011-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090170-003LAMOTRIGINE150MGTABLET / ORALAB2011-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090170-004LAMOTRIGINE200MGTABLET / ORALAB2011-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090170-001LAMOTRIGINE25MGTABLET / ORALAB2011-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090170-002LAMOTRIGINE100MGTABLET / ORALAB2011-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090170-003LAMOTRIGINE150MGTABLET / ORALAB2011-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090170-004LAMOTRIGINE200MGTABLET / ORALAB2011-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090170-001LAMOTRIGINE25MGTABLET / ORALAB2011-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090170-002LAMOTRIGINE100MGTABLET / ORALAB2011-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090170-003LAMOTRIGINE150MGTABLET / ORALAB2011-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090170-004LAMOTRIGINE200MGTABLET / ORALAB2011-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090170-001LAMOTRIGINE25MGTABLET / ORALAB2011-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090170-002LAMOTRIGINE100MGTABLET / ORALAB2011-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090170-003LAMOTRIGINE150MGTABLET / ORALAB2011-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090170-004LAMOTRIGINE200MGTABLET / ORALAB2011-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090170-001LAMOTRIGINE25MGTABLET / ORALAB2011-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090170-002LAMOTRIGINE100MGTABLET / ORALAB2011-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090170-003LAMOTRIGINE150MGTABLET / ORALAB2011-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090170-004LAMOTRIGINE200MGTABLET / ORALAB2011-10-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090170-001LAMOTRIGINE25MGTABLET / ORALAB2011-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090170-002LAMOTRIGINE100MGTABLET / ORALAB2011-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090170-003LAMOTRIGINE150MGTABLET / ORALAB2011-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090170-004LAMOTRIGINE200MGTABLET / ORALAB2011-10-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090170-001LAMOTRIGINE25MGTABLET / ORALAB2011-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090170-002LAMOTRIGINE100MGTABLET / ORALAB2011-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090170-003LAMOTRIGINE150MGTABLET / ORALAB2011-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090170-004LAMOTRIGINE200MGTABLET / ORALAB2011-10-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090170-001LAMOTRIGINE25MGTABLET / ORALAB2011-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A090170-002LAMOTRIGINE100MGTABLET / ORALAB2011-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A090170-003LAMOTRIGINE150MGTABLET / ORALAB2011-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A090170-004LAMOTRIGINE200MGTABLET / ORALAB2011-10-06d06236e962d9…

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 UTC2026-02A090170-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090170-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090170-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090170-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090170-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090170-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090170-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090170-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090170-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090170-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090170-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090170-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090170-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090170-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090170-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090170-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090170-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090170-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090170-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090170-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090170-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090170-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090170-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090170-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090170-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090170-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090170-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090170-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090170-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090170-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090170-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090170-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090170-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090170-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090170-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090170-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090170-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090170-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090170-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090170-004AB1d06236e962d9…

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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LamotrigineLAMOTRIGINEREMEDYREPACK INC.d1691a60-ff0a-4755-b445-1d78309d5af02026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINEREMEDYREPACK INC.346f8af3-b850-48e4-bd6e-82ecafca86d22026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINEREMEDYREPACK INC.f5761818-4eaf-4335-a77a-9cd703278ded2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINEREMEDYREPACK INC.1b5646a9-4724-44b8-8cd0-9c14f5e87f862026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINECoupler LLC55f41c7e-03a6-b84c-e063-6294a90a7d822026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINEREMEDYREPACK INC.3ed4590d-71e3-4208-b6c0-98330acc7b852026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINECoupler LLC545fcc0e-1e2b-bdcb-e063-6294a90a4ac72026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINEBryant Ranch Prepackb1601109-5c17-4482-9257-1e0be7546e8f2026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINECoupler LLC52b8be5c-ef88-dfa7-e063-6394a90a05002026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINEUnichem Pharmaceuticals (USA), Inc.4b72ea7a-a0b0-4980-84ad-84f64e2e63682026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
ndc (product): 29300-113
ndc (product): 29300-114
ndc (product): 29300-111
ndc (product): 29300-112
LamotrigineLAMOTRIGINEPreferred Pharmaceuticals, Inc.16323699-9bf8-43c7-b3aa-5891563778722026-05-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINEPreferred Pharmaceuticals Inc.09a0d30d-9b8f-4c76-8cdb-8492386b22542026-05-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
ndc (product): 68788-7223
LamotrigineLAMOTRIGINEA-S Medication Solutions6139a858-700c-4eb9-9f84-99d280bde3262026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
ndc (product): 50090-2130
ndc (product): 50090-2129
ndc (product): 50090-2131
LamotrigineLAMOTRIGINEPD-Rx Pharmaceuticals, Inc.dc6e6735-d49a-44d8-936d-7c33437bc59e2026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINEREMEDYREPACK INC.811188be-d231-4b58-8d7a-b01b236fab512026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINENorthwind Health Company, LLCdb5f7ee5-9bd9-1819-e053-2a95a90a91df2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINEA-S Medication Solutions84277e2c-370c-4510-92bc-ef33a4a0f5082025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
ndc (product): 50090-3914
LamotrigineLAMOTRIGINEBryant Ranch Prepack8e1e4fa8-881c-4618-88f6-018ab15db44d2025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINEBryant Ranch Prepack812bc0d8-bb31-4fb1-9f4a-f8c17cbc769c2025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINEBryant Ranch Prepack53774022-ea0c-42a9-a720-dc755c77b8512025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 139 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
29300-111LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-111LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-111LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-111LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-111LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-111LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-111LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-112LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-112LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-112LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-112LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-112LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-112LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-112LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-113LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-113LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-113LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-113LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-113LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-113LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-113LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-114LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-114LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-114LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-114LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-114LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-114LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-114LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
33261-648LamotrigineLamotrigineAidarex Pharmaceuticals LLCANDACurrent
50090-2129LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-2129LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-2129LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-2129LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-2130LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-2130LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-2130LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-2131LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-2131LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-3914LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-3914LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-3914LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-3914LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
53002-2512LamotrigineLamotrigineRPK Pharmaceuticals, Inc.ANDACurrent
53002-2513LamotrigineLamotrigineRPK Pharmaceuticals, Inc.ANDACurrent
53808-0993LamotrigineLamotrigineState of Florida DOH Central PharmacyANDACurrent
55700-626LamotrigineLamotrigineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-626LamotrigineLamotrigineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-626LamotrigineLamotrigineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-626LamotrigineLamotrigineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-626LamotrigineLamotrigineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-626LamotrigineLamotrigineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-683LamotrigineLamotrigineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-683LamotrigineLamotrigineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-683LamotrigineLamotrigineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-683LamotrigineLamotrigineLake Erie Medical DBA Quality Care Products LLCANDACurrent
58118-1111LamotrigineLamotrigineClinical Solutions Wholesale, LLCANDACurrent
58118-1111LamotrigineLamotrigineClinical Solutions Wholesale, LLCANDACurrent
60760-050LamotrigineLamotrigineSt. Mary's Medical Park PharmacyANDACurrent
61919-534LAMOTRIGINELAMOTRIGINEDirectRXANDACurrent
61919-534LAMOTRIGINELAMOTRIGINEDirectRXANDACurrent
61919-777LAMOTRIGINELAMOTRIGINEDirect RXANDACurrent
61919-802LAMOTRIGINELAMOTRIGINEDIRECT RXANDACurrent
61919-802LAMOTRIGINELAMOTRIGINEDIRECT RXANDACurrent
63187-487LamotrigineLamotrigineProficient Rx LPANDACurrent
63187-487LamotrigineLamotrigineProficient Rx LPANDACurrent
63187-487LamotrigineLamotrigineProficient Rx LPANDACurrent
64725-0111LamotrigineLamotrigineTYA PharmaceuticalsANDACurrent
64725-0112LamotrigineLamotrigineTYA PharmaceuticalsANDACurrent
68071-2054LamotrigineLamotrigineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2729LamotrigineLamotrigineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2873LamotrigineLamotrigineNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7168LamotrigineLamotriginePreferred Pharmaceuticals Inc.ANDACurrent
68788-7168LamotrigineLamotriginePreferred Pharmaceuticals Inc.ANDACurrent
68788-7168LamotrigineLamotriginePreferred Pharmaceuticals Inc.ANDACurrent
68788-7168LamotrigineLamotriginePreferred Pharmaceuticals Inc.ANDACurrent
68788-7168LamotrigineLamotriginePreferred Pharmaceuticals Inc.ANDACurrent
68788-7223LamotrigineLamotriginePreferred Pharmaceuticals Inc.ANDACurrent
68788-7223LamotrigineLamotriginePreferred Pharmaceuticals Inc.ANDACurrent
68788-7223LamotrigineLamotriginePreferred Pharmaceuticals Inc.ANDACurrent
68788-7223LamotrigineLamotriginePreferred Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43235ORIG2011-12-16
18533ORIG2011-12-16