FDA.reportPublic FDA data

Application 021423

Type
NDA
Sponsor
PARKE DAVIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEURONTINGABAPENTINCAPSULE; ORAL800MGNoNo

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 7 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINStrides Pharma Science Limited798575b9-ddfa-4915-9574-626abbaf025f2026-04-04Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack75caca13-1432-4c0d-8d45-f029b0b2d4172026-03-31Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack56378630-e7a7-4981-8212-8ea703a433d82026-03-31Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINST. MARY'S MEDICAL PARK PHARMACY4ddc1342-5c83-f562-e063-6294a90a29ba2026-03-25Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCafc83432-8fce-6d2a-e053-2a95a90ae73f2026-03-19Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINPD-Rx Pharmaceuticals, Inc.81774da8-cb1d-4c7d-8550-35396850d5ff2026-03-18Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack912d8697-b466-48dc-88d3-d2ba90e766442026-03-12Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINRadha Pharmaceuticals, Inc.1045db4e-4c76-4a0d-bf12-019bd96a8f592026-03-11Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINDirect_Rx0b286fd1-8179-d87a-e063-6294a90a2f232026-03-05Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAmerican Health Packaginge00f5048-1a06-44f4-b244-aa2755f4be222026-03-02Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINSolco Healthcare US, LLC360d953b-4313-45ae-b933-296547d4577d2026-02-28Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINA-S Medication Solutions54c09aa5-6724-480a-a115-c88484e39e932026-02-24Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAdvagen Pharma Ltd401b30fc-e143-4906-aae1-e5b5c190d4a82026-02-24Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAdvagen Pharma Ltdbfee67dc-d2b1-4a00-92d9-a42be3189c742026-02-24Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINScieGen Pharmaceuticals, Inc.5ab9c18b-9568-4dcb-90b0-252aef8f8dc22026-02-20Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.9814b76c-87c6-4746-b712-3269352a901b2026-02-16Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.d8daa30f-1cb3-46aa-9b68-d9aa5b0a21052026-02-12Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINA-S Medication Solutionsc979f80b-d4b1-40f7-b878-b216db5f325d2026-02-10Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINA-S Medication Solutionsb88b0cbc-c883-4d17-8f46-0e5bddc578352026-02-10Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINA-S Medication Solutions3dbd447f-4791-4c62-86b4-6f79288627852026-02-10Warnings, 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
24146ORIG2008-02-01
36870ORIG2004-06-09
27726ORIG2004-06-09
42146ORIG2004-05-06