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 14 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCafa28969-91ca-83fd-e053-2a95a90a656b2024-12-31Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCafa28969-91c8-83fd-e053-2a95a90a656b2024-12-31Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINADVANCED RX OF TENNESSEE, LLCaf73fbd8-9731-e6bf-e053-2995a90af65d2024-12-31Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCafc80b8b-da39-6fb9-e053-2a95a90a2d8e2024-12-31Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCb062f12c-a745-76d4-e053-2a95a90a3a1a2024-12-31Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCb33c18ea-554d-3cfb-e053-2a95a90a2dd12024-12-31Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCb37b1dcc-c7e9-8845-e053-2995a90a089e2024-12-31Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAdvanced Rx Pharmacy of Tennessee, LLCc898711b-9a65-1816-e053-2995a90a855e2024-12-31Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCd294f6aa-ed82-90a2-e053-2995a90a28962024-12-31Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAdvanced Rx Pharmacy of Tennessee, LLCec1c621b-db2a-1567-e053-2995a90a86952024-12-31Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAdvanced Rx Pharmacy of Tennessee, LLCc89a68b6-6dc0-4624-e053-2a95a90a687e2024-12-31Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAdvanced Rx Pharmacy of Tennessee, LLCbc08e35d-ef5d-1dcd-e053-2a95a90ab5de2024-12-31Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAdvanced Rx Pharmacy of Tennessee, LLCc859e666-d510-426b-e053-2995a90a9a3c2024-12-31Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAdvanced Rx Pharmacy of Tennessee, LLCebf57adf-b066-2959-e053-2a95a90a961c2024-12-31Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCec1a01fe-5531-21df-e053-2a95a90a05612024-12-31Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAdvanced Rx Pharmacy of Tennessee, LLCf781d400-7304-5d3e-e053-6294a90ac5722024-12-31Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINCamber Pharmaceuticals, Inc.e8a30eb7-3fc5-456a-bdae-3f4095bf2c2b2024-12-26Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINWestminster Pharmaceuticals, LLC2eec52a1-9016-46dd-8b4c-8dab1d0aeece2024-12-23Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINQuality Care Products, LLCed3a0d48-2e98-44ee-8743-880d1221a4802024-12-18Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINBryant Ranch Prepack6e7f602a-2c5f-4651-a228-5fc5bf2492052024-12-10Warnings, 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