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 10 of 21 · 402 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINA-S Medication Solutionsaa246838-609c-4254-a8ec-d6f463a179602025-10-16Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepackefb86e22-5a84-4b33-aad0-71dd5a2c6c8f2025-10-13Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINA-S Medication Solutions1ead7343-ab25-41b5-af4f-f903470e1dd92025-10-10Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINA-S Medication Solutions781b0d62-a760-4371-8908-1f61329928a62025-10-10Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GABAPENTINGABAPENTINSTALLION LABORATORIES PRIVATE LIMITEDb26fd0c6-6aab-4957-8a32-cc7adb9b5fc92025-10-03Warnings, Adverse reactionsName fallback
brand name: GABAPENTIN
generic name: GABAPENTIN
GabapentinGABAPENTINAmerican Health Packagingbbfdedd7-2baf-4bc6-be59-548a5cf217522025-10-03Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepackbe9a572d-e98a-41c1-83c5-859d9176dd1c2025-10-03Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepackeaf5e41e-8ed3-404e-84e0-392bebdbc0b72025-10-03Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GABAPENTINGABAPENTINProficient Rx LPda8438e1-755b-4195-baa7-464f3d9ee5bd2025-10-01Warnings, Adverse reactionsName fallback
brand name: GABAPENTIN
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack8f982b95-4e84-4e0c-a543-747bc3dd75312025-09-26Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepackd0510d04-460c-47d1-be72-0ee32c4ac6402025-09-26Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack344d67fa-092e-4e71-b96a-25c71bfa6bb12025-09-25Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepackbc1316b6-1fc4-4990-95a8-4898817728762025-09-25Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINKesin Pharma Corporation3f2ba3d6-6086-eaf2-e063-6294a90a76422025-09-19Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
gabapentinGABAPENTINCoupler LLC3eeda97d-c3cd-65cd-e063-6394a90aae8b2025-09-16Warnings, Adverse reactionsName fallback
brand name: gabapentin
generic name: GABAPENTIN
gabapentinGABAPENTINZydus Lifesciences Limited8c0eeefc-ef5b-49f4-8411-ddbae312ed052025-09-15Name fallback
brand name: gabapentin
generic name: GABAPENTIN
GABAPENTINGABAPENTINMARKSANS PHARMA LIMITED98bb408d-c402-4da6-8f9d-5de4833dedc42025-09-12Warnings, Adverse reactionsName fallback
brand name: GABAPENTIN
generic name: GABAPENTIN
GabapentinGABAPENTINEpic Pharma, LLCd592d828-8df1-480d-b179-bb9260a9c8242025-09-12Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINZydus Pharmaceuticals USA Inc.310ce005-5a24-489a-b23c-d42ab6a3bfed2025-09-08Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
gabapentinGABAPENTINZydus Pharmaceuticals USA Inc.3cfd04ab-e421-441f-a10e-e4dd1412974d2025-09-05Warnings, 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