FDA.reportPublic FDA data

Application 203611

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GABAPENTINGABAPENTINTABLET; ORAL300MGNoNo
002GABAPENTINGABAPENTINTABLET; ORAL600MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203611-001GABAPENTINGABAPENTIN300MGTABLET / ORALAB22026-06-23
A203611-002GABAPENTINGABAPENTIN600MGTABLET / ORALAB22026-06-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A203611-001AB2
A203611-002AB2

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A203611-001GABAPENTIN300MGTABLET / ORALAB22026-06-2384e616aacf4f…
2026-09-14 22:38:342026-08A203611-002GABAPENTIN600MGTABLET / ORALAB22026-06-2384e616aacf4f…
2026-08-18 06:07:402026-07A203611-001GABAPENTIN300MGTABLET / ORALAB22026-06-23caaa826d4ba7…
2026-08-18 06:07:402026-07A203611-002GABAPENTIN600MGTABLET / ORALAB22026-06-23caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A203611-001GABAPENTIN300MGTABLET / ORALAB22026-06-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A203611-002GABAPENTIN600MGTABLET / ORALAB22026-06-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A203611-001AB2184e616aacf4f…
2026-09-14 22:38:342026-08A203611-002AB2184e616aacf4f…
2026-08-18 06:07:402026-07A203611-001AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A203611-002AB21caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A203611-001AB21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A203611-002AB21a50c72e98297…

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 17 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINBryant Ranch Prepack9efd0261-9fc9-4dc9-8cf3-9110157ddfc42024-04-03Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepackb4954172-5439-48fd-8348-8a2e0d2fee622024-04-02Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack01b810b7-f4c8-4412-bbc5-b9220d8770d82024-04-02Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepackc9944562-563a-423d-972c-f0313375d2342024-04-02Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINMedsource Pharmaceuticals12f0c2ee-9a44-9778-e063-6294a90a3b582024-03-05Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LP1749d731-bc8c-4374-b2a9-7c809c457f562024-03-01Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINMedsource Pharmaceuticals1278512b-1493-db65-e063-6394a90ab1612024-02-28Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC7a2aa696-7dac-4d03-916a-374b61a255b52024-02-16Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC79cd9dea-e7d0-44db-afba-964cb99f32b62024-01-31Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLCf9bf87e4-5499-4dd7-a0c1-16025a718d142024-01-09Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GABAPENTINGABAPENTINAphena Pharma Solutions - Tennessee, LLCf38098ec-dd1a-405a-bbfb-bad62e4e7fa52024-01-04Warnings, Adverse reactionsName fallback
brand name: GABAPENTIN
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack56967a93-b3c0-4043-9241-585fc64e26242023-12-20Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepacke286ed87-5fbc-4ff2-a05e-1f7fa658bbfc2023-12-20Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack0eb27e64-1488-4083-82c7-cebb8c0605de2023-12-20Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINA-S Medication Solutionsecb798a0-377d-4712-bb82-ec9d7116962f2023-12-09Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GABAPENTINGABAPENTINA-S Medication Solutions40bb60c0-a2f3-4e7f-b13c-028c906c48522023-11-01Warnings, Adverse reactionsName fallback
brand name: GABAPENTIN
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LP9c96b488-19bd-431e-af9a-b313ffd9eaae2023-10-01Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GABAPENTINGABAPENTINAsclemed USA, Inc.5fb79774-c2d4-47ba-9a16-eb367d0fdcff2023-09-30Warnings, Adverse reactionsName fallback
brand name: GABAPENTIN
generic name: GABAPENTIN
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLCaf62bb7e-162e-4e2a-8eb0-d50f666787072023-09-22Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINA-S Medication Solutions77d1d90d-e124-4db7-b811-754d535e579c2023-09-10Warnings, 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.