FDA.reportPublic FDA data

Application 021424

Type
NDA
Sponsor
PARKE DAVIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEURONTINGABAPENTINSOLUTION; ORAL250MG/5MLNoNo

Source provenance: Browse the complete Orange Book source catalog.

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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24147ORIG2008-02-01
36871ORIG2004-06-09
5315ORIG2004-06-09
42147ORIG2004-05-06