FDA.reportPublic FDA data

Application 078150

Type
ANDA
Sponsor
HIKMA

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
A078150-001GABAPENTINGABAPENTIN100MGCAPSULE / ORAL2007-09-25
A078150-002GABAPENTINGABAPENTIN300MGCAPSULE / ORAL2007-09-25
A078150-003GABAPENTINGABAPENTIN400MGCAPSULE / ORAL2007-09-25

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 22:38:342026-08A078150-001GABAPENTIN100MGCAPSULE / ORAL2007-09-2584e616aacf4f…
2026-09-14 22:38:342026-08A078150-002GABAPENTIN300MGCAPSULE / ORAL2007-09-2584e616aacf4f…
2026-09-14 22:38:342026-08A078150-003GABAPENTIN400MGCAPSULE / ORAL2007-09-2584e616aacf4f…
2026-08-18 06:07:402026-07A078150-001GABAPENTIN100MGCAPSULE / ORAL2007-09-25caaa826d4ba7…
2026-08-18 06:07:402026-07A078150-002GABAPENTIN300MGCAPSULE / ORAL2007-09-25caaa826d4ba7…
2026-08-18 06:07:402026-07A078150-003GABAPENTIN400MGCAPSULE / ORAL2007-09-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078150-001GABAPENTIN100MGCAPSULE / ORAL2007-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078150-002GABAPENTIN300MGCAPSULE / ORAL2007-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078150-003GABAPENTIN400MGCAPSULE / ORAL2007-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078150-001GABAPENTIN100MGCAPSULE / ORAL2007-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078150-002GABAPENTIN300MGCAPSULE / ORAL2007-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078150-003GABAPENTIN400MGCAPSULE / ORAL2007-09-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078150-001GABAPENTIN100MGCAPSULE / ORAL2007-09-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078150-002GABAPENTIN300MGCAPSULE / ORAL2007-09-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078150-003GABAPENTIN400MGCAPSULE / ORAL2007-09-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078150-001GABAPENTIN100MGCAPSULE / ORAL2007-09-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078150-002GABAPENTIN300MGCAPSULE / ORAL2007-09-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078150-003GABAPENTIN400MGCAPSULE / ORAL2007-09-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078150-001GABAPENTIN100MGCAPSULE / ORAL2007-09-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078150-002GABAPENTIN300MGCAPSULE / ORAL2007-09-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078150-003GABAPENTIN400MGCAPSULE / ORAL2007-09-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078150-001GABAPENTIN100MGCAPSULE / ORAL2007-09-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078150-002GABAPENTIN300MGCAPSULE / ORAL2007-09-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078150-003GABAPENTIN400MGCAPSULE / ORAL2007-09-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078150-001GABAPENTIN100MGCAPSULE / ORAL2007-09-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078150-002GABAPENTIN300MGCAPSULE / ORAL2007-09-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078150-003GABAPENTIN400MGCAPSULE / ORAL2007-09-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078150-001GABAPENTIN100MGCAPSULE / ORAL2007-09-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078150-002GABAPENTIN300MGCAPSULE / ORAL2007-09-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078150-003GABAPENTIN400MGCAPSULE / ORAL2007-09-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078150-001GABAPENTIN100MGCAPSULE / ORAL2007-09-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078150-002GABAPENTIN300MGCAPSULE / ORAL2007-09-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078150-003GABAPENTIN400MGCAPSULE / ORAL2007-09-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078150-001GABAPENTIN100MGCAPSULE / ORAL2007-09-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A078150-002GABAPENTIN300MGCAPSULE / ORAL2007-09-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A078150-003GABAPENTIN400MGCAPSULE / ORAL2007-09-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078150-001GABAPENTIN100MGCAPSULE / ORAL2007-09-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078150-002GABAPENTIN300MGCAPSULE / ORAL2007-09-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078150-003GABAPENTIN400MGCAPSULE / ORAL2007-09-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078150-001GABAPENTIN100MGCAPSULE / ORAL2007-09-25301d65b070ca…

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 14 of 21 · 402 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GABAPENTINGABAPENTINDIRECT RXa7e45e3f-e382-32ba-e053-2a95a90a25372025-01-17Name fallback
brand name: GABAPENTIN
generic name: GABAPENTIN
GabapentinGABAPENTINClinical Solutions Wholesale, LLC743faa18-5e7c-4fcc-9781-4157450d90c42025-01-16Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.bd5c9279-a1e3-2a59-e053-2a95a90a33a22025-01-14Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC41ce952c-6c16-4b5d-adf7-9ea114e63eb32025-01-09Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC13b87441-8fe1-40f5-8ffb-00dcd8cc90a62025-01-09Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINAvPAKfaa47fcd-2545-a946-e053-6294a90a05d22025-01-09Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC95757436-2093-41cf-a9a9-ef2f28ac096f2025-01-09Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.2b395a14-0f8e-7f5b-e063-6294a90ab5462025-01-08Warnings, Adverse reactionsName fallback
brand name: GABAPENTIN
generic name: GABAPENTIN
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCafa28969-91ca-83fd-e053-2a95a90a656b2024-12-31Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCafa28969-91c8-83fd-e053-2a95a90a656b2024-12-31Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINADVANCED RX OF TENNESSEE, LLCaf73fbd8-9731-e6bf-e053-2995a90af65d2024-12-31Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCafc80b8b-da39-6fb9-e053-2a95a90a2d8e2024-12-31Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCb062f12c-a745-76d4-e053-2a95a90a3a1a2024-12-31Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCb33c18ea-554d-3cfb-e053-2a95a90a2dd12024-12-31Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCb37b1dcc-c7e9-8845-e053-2995a90a089e2024-12-31Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINAdvanced Rx Pharmacy of Tennessee, LLCc898711b-9a65-1816-e053-2995a90a855e2024-12-31Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCd294f6aa-ed82-90a2-e053-2995a90a28962024-12-31Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINAdvanced Rx Pharmacy of Tennessee, LLCec1c621b-db2a-1567-e053-2995a90a86952024-12-31Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINAdvanced Rx Pharmacy of Tennessee, LLCc89a68b6-6dc0-4624-e053-2a95a90a687e2024-12-31Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINAdvanced Rx Pharmacy of Tennessee, LLCbc08e35d-ef5d-1dcd-e053-2a95a90ab5de2024-12-31Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN

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 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-3991GabapentinGabapentinWest-ward Pharmaceutical CorpANDACurrent
0143-3993GabapentinGabapentinWest-ward Pharmaceutical CorpANDACurrent
0143-3994GabapentinGabapentinWest-ward Pharmaceutical CorpANDACurrent
0143-9992GabapentinGabapentinWest-ward Pharmaceutical CorpANDACurrent
0143-9993GabapentinGabapentinWest-ward Pharmaceutical CorpANDACurrent
0143-9994GabapentinGabapentinWest-ward Pharmaceutical CorpANDACurrent
59115-073GabapentinGabapentinHikma PharmaceuticalANDACurrent
59115-073GabapentinGabapentinHikma PharmaceuticalANDACurrent
59115-074GabapentinGabapentinHikma PharmaceuticalANDACurrent
59115-074GabapentinGabapentinHikma PharmaceuticalANDACurrent
59115-075GabapentinGabapentinHikma PharmaceuticalANDACurrent
59115-075GabapentinGabapentinHikma PharmaceuticalANDACurrent
66336-439GabapentinGabapentinDispensing Solutions, Inc.ANDACurrent
66336-567GabapentinGabapentinDispensing Solutions, Inc.ANDACurrent