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 18 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINProficient Rx LP22f2294f-352a-4515-87c8-a6ae46e613222023-05-01Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GABAPENTINGABAPENTINExelan Pharmaceuticals Inc.323dad14-ded9-4432-a265-c957e46cc6db2023-03-23Warnings, Adverse reactionsName fallback
brand name: GABAPENTIN
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LP35004f84-90ae-45f0-a2ba-653dec5072292023-03-01Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINCipla USA Inc.7c3ac86f-b8f7-42bf-942a-db854d946e542023-01-20Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LPf7a943ec-9a13-45ba-9bc5-18162b86b9212023-01-01Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC20e48004-d8b6-40fd-929b-b95087b4d85d2022-11-28Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LPc7cb37f9-e1df-4e2a-bde5-9bfa0e040d7a2022-11-01Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC88ac51c4-5fa9-4c35-9c63-f26bcb101d4b2022-10-18Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINAsclemed USA, Inc.e89a7ff2-bd82-4fde-b2b7-3b9d0edf6fc82022-10-12Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINAsclemed USA, Inc.9d544944-ea95-42e1-8c65-9e442437f0ee2022-10-10Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LPf651a143-3f88-49c9-b5c4-c9af55aea76a2022-10-01Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LP176c5b60-93c2-4574-8b51-c15180912aaa2022-08-01Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
NeurontinGABAPENTINParke-Davis Div of Pfizer Incee9ad9ed-6d9f-4ee1-9d7f-cfad438df3882022-07-12Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAsclemed USA, Inc.14b1840d-a2db-4eec-bc25-029e35b042e42022-07-09Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINAsclemed USA, Inc.c18d9d06-f796-4eb7-8fd5-1de4ebb954392022-07-07Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GABAPENTINGABAPENTINAphena Pharma Solutions - Tennessee, LLC17988b64-723c-488d-befd-3e4e4cc44bd22022-05-11Warnings, Adverse reactionsName fallback
brand name: GABAPENTIN
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LPed22b78e-93ff-4cb5-9c9c-2afe9b60dd2e2022-05-02Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LP645824d0-eb3d-442b-806d-36a70796cb8e2022-05-01Warnings, Adverse reactionsName fallback
brand name: Gabapentin
generic name: GABAPENTIN
GABAPENTINGABAPENTINProficient Rx LPaa3ab216-372a-4a72-bfd1-88a1ffa31ba32022-05-01Warnings, Adverse reactionsName fallback
brand name: GABAPENTIN
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LPb67b7865-df64-429a-9550-5333b9c713ea2022-04-01Warnings, 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.