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 19 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINProficient Rx LP223a9216-6e07-49b9-8faf-bb4e529a6ae52022-04-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LP2fb2233f-9152-4630-ab39-51a0cda7e5ca2022-04-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LP52af51ab-6543-466b-848c-13c588c987892022-04-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LP2b76955c-52a4-4026-b286-3da1112fe9892022-04-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
gabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC7790d906-af26-4e60-bc6f-e906ec03cc242022-03-21Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINAphena Pharma Solutions - Tennessee, LLC7f579665-afb7-4227-98c1-2eafee6505042022-02-28Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINProficient Rx LP185f264e-db32-41cd-b90d-519717b978502021-11-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAmneal Pharmaceuticals of New York LLCb11dbff5-ceee-4a63-a093-f6efebdc2f6f2021-02-03Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LPf6baeb5c-ca9c-4730-aeb8-8f8732e8ca3a2021-01-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LPc79d94ec-117d-4fb6-845d-1954e3472bb02021-01-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
Gaba 300-EZSGABAPENTINPureTek Corporationbb29692e-1546-4d05-a46a-93baf4172c7d2020-11-16Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC3b4395f2-9440-4b67-97cc-5d16f3bdd05e2020-08-14Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC39149f0e-30ed-4671-8be7-2a484f65d63b2020-08-05Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LPded42b88-94dd-462d-bcdf-7fd34d1e49c32020-07-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINAsclemed USA, Inc.45039bba-7a96-450c-95be-83a3aa4fcbd22020-06-10Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LP8b2f38ef-0a0c-45cc-88ca-cc086bf806412020-06-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLCba2a8352-5776-4edb-914e-ce1d18ccda322020-05-27Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LPc09c66fd-cb31-41dd-b00b-acc58bd809f72020-01-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LP7d77dae0-df76-4b7b-9690-713e9a60e3cd2019-12-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINProficient Rx LP4bae5032-f634-4d1e-b672-8a7e2bd6a5fa2019-11-01Warnings, 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