Application 090858

Type
ANDA
Sponsor
ALKEM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GABAPENTINGABAPENTINCAPSULE;ORAL100MGNoNo
002GABAPENTINGABAPENTINCAPSULE;ORAL300MGNoNo
003GABAPENTINGABAPENTINCAPSULE;ORAL400MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090858-001GABAPENTINGABAPENTIN100MGCAPSULE / ORALAB2010-12-17
A090858-002GABAPENTINGABAPENTIN300MGCAPSULE / ORALAB2010-12-17
A090858-003GABAPENTINGABAPENTIN400MGCAPSULE / ORALAB2010-12-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A090858-001AB
A090858-002AB
A090858-003AB

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-1784e616aacf4f…
2026-09-14 22:38:342026-08A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-1784e616aacf4f…
2026-09-14 22:38:342026-08A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-1784e616aacf4f…
2026-08-18 06:07:402026-07A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A090858-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090858-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A090858-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A090858-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090858-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090858-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090858-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090858-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090858-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090858-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090858-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090858-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090858-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090858-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090858-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090858-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090858-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090858-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090858-001AB1301d65b070ca…

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 2 of 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCafc83432-8fce-6d2a-e053-2a95a90ae73f2026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINREMEDYREPACK INC.09736975-2493-4dbc-bbe0-cc56a1fec53f2026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINA-S Medication Solutionsc979f80b-d4b1-40f7-b878-b216db5f325d2026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINAmerican Health Packagingbbfdedd7-2baf-4bc6-be59-548a5cf217522025-10-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINMcKesson Corporation dba Sky Packaging23eb133e-2f74-4219-9892-0a8e770ec0322025-04-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINClinical Solutions Wholesale, LLC743faa18-5e7c-4fcc-9781-4157450d90c42025-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINAdvanced Rx Pharmacy of Tennessee, LLCc89a68b6-6dc0-4624-e053-2a95a90a687e2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.a072d5d2-8c75-59cc-e053-2a95a90ac0cc2024-11-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINA-S Medication Solutions77d1d90d-e124-4db7-b811-754d535e579c2023-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
ndc (product): 50090-4893
GabapentinGABAPENTINProficient Rx LP176c5b60-93c2-4574-8b51-c15180912aaa2022-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINAsclemed USA, Inc.14b1840d-a2db-4eec-bc25-029e35b042e42022-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINProficient Rx LP2ef99c3d-866a-438b-a340-8beba8d4c4572019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLCf455b415-12a2-4916-b826-246976a8af442018-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC6fc8e8b2-5d0e-4c72-9a46-6d312c3efac72018-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858

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 4 · 241 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6665GabapentinGabapentinMajor PharmaceuticalsANDACurrent
0904-6665GabapentinGabapentinMajor PharmaceuticalsANDACurrent
0904-6665GabapentinGabapentinMajor PharmaceuticalsANDACurrent
0904-6665GabapentinGabapentinMajor PharmaceuticalsANDACurrent
0904-6666GabapentinGabapentinMajor PharmaceuticalsANDACurrent
0904-6666GabapentinGabapentinMajor PharmaceuticalsANDACurrent
0904-6666GabapentinGabapentinMajor PharmaceuticalsANDACurrent
0904-6666GabapentinGabapentinMajor PharmaceuticalsANDACurrent
0904-6667GabapentinGabapentinMajor PharmaceuticalsANDACurrent
0904-6667GabapentinGabapentinMajor PharmaceuticalsANDACurrent
0904-6667GabapentinGabapentinMajor PharmaceuticalsANDACurrent
0904-6667GabapentinGabapentinMajor PharmaceuticalsANDACurrent
16714-503GabapentinGabapentinNorthStar RxLLCANDACurrent
16714-504GabapentinGabapentinNorthStar RxLLCANDACurrent
16714-505GabapentinGabapentinNorthStar RxLLCANDACurrent
42708-056GabapentinGabapentinQPharma IncANDACurrent
42708-056GabapentinGabapentinQPharma IncANDACurrent
42708-120GabapentinGabapentinQPharma IncANDACurrent
42708-120GabapentinGabapentinQPharma IncANDACurrent
42708-120GabapentinGabapentinQPharma IncANDACurrent
43063-673GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-673GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-673GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-673GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-673GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-673GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-673GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-673GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-687GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-549GabapentinGabapentinmedsource pharmaceuticalsANDACurrent
50090-0896GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-0896GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-0896GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-0896GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-0896GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-0896GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-0896GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-0896GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-2107GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-2107GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-2107GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-2107GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-2107GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-2107GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-2847GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-3200GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-3200GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-3200GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-3200GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-3200GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-3200GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-3582GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-4893GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-5125GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-5125GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-5961GabapentinGabapentinA-S Medication SolutionsANDACurrent
50436-0223GabapentinGabapentinUnit Dose ServicesANDACurrent
50436-0223GabapentinGabapentinUnit Dose ServicesANDACurrent
50436-0223GabapentinGabapentinUnit Dose ServicesANDACurrent
50436-0224GabapentinGabapentinUnit Dose ServicesANDACurrent
50436-0224GabapentinGabapentinUnit Dose ServicesANDACurrent
50436-0224GabapentinGabapentinUnit Dose ServicesANDACurrent
53217-268GabapentinGabapentinAidarex Pharmaceuticals LLCANDACurrent
53217-284GabapentinGabapentinAidarex Pharmaceuticals LLCANDACurrent
55154-3363GabapentinGabapentinCardinal Health 107, LLCANDACurrent
55154-3363GabapentinGabapentinCardinal HealthANDACurrent
55154-7992GabapentinGabapentinCardinal Health 107, LLCANDACurrent
55154-7992GabapentinGabapentinCardinal HealthANDACurrent
55154-7992GabapentinGabapentinCardinal HealthANDACurrent
55154-7992GabapentinGabapentinCardinal HealthANDACurrent
55154-7993GabapentinGabapentinCardinal Health 107, LLCANDACurrent
55154-7993GabapentinGabapentinCardinal HealthANDACurrent
55154-7993GabapentinGabapentinCardinal HealthANDACurrent
55154-7993GabapentinGabapentinCardinal HealthANDACurrent
55154-8194GabapentinGabapentinCardinal Health 107, LLCANDACurrent
55154-8194GabapentinGabapentinCardinal HealthANDACurrent
55154-8195GabapentinGabapentinCardinal Health 107, LLCANDACurrent
55154-8195GabapentinGabapentinCardinal HealthANDACurrent
55695-016GabapentinGabapentinDepartment of State Health Services, Pharmacy BranchANDACurrent
55700-544GabapentinGabapentinLake Erie Medical DBA Quality Care Products LLCANDACurrent