FDA.reportPublic FDA data

Application 021216

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 13 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.febf610e-e088-4797-e053-6294a90a3eb52025-02-04Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.07871ab8-254b-e3c2-e063-6294a90a29ab2025-02-03Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.0919fed8-e968-b5ac-e063-6294a90afbff2025-02-03Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepacka1ff94a9-69c4-486a-aab2-563c7ed244c82025-01-30Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINCoupler LLC2cdbb381-88a2-5c5a-e063-6294a90a3e1e2025-01-29Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINNuCare Pharmaceuticals, Inc.2c65253d-ca49-70eb-e063-6394a90a3cd22025-01-23Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINDirect_Rxe90d2e3d-ec86-7d1d-e053-2995a90a91672025-01-22Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINDirect_Rxed9cb5fe-7a2e-e0bc-e053-2a95a90a44702025-01-22Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINDirect_Rxf40a4ee4-ae8e-769c-e053-2a95a90a344e2025-01-22Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINDirectrxd5c9dd2c-b8ee-1406-e053-2995a90a02872025-01-21Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINPreferred Pharmaceuticals Inc.db57e37f-0a78-4c14-8768-a28bbf9fa0da2025-01-21Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINDIRECT RXa5b47f89-ed35-31de-e053-2a95a90a55542025-01-17Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINDIRECT RXa7e45e3f-e382-32ba-e053-2a95a90a25372025-01-17Name fallback
generic name: GABAPENTIN
GabapentinGABAPENTINClinical Solutions Wholesale, LLC743faa18-5e7c-4fcc-9781-4157450d90c42025-01-16Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.bd5c9279-a1e3-2a59-e053-2a95a90a33a22025-01-14Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC41ce952c-6c16-4b5d-adf7-9ea114e63eb32025-01-09Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC13b87441-8fe1-40f5-8ffb-00dcd8cc90a62025-01-09Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAvPAKfaa47fcd-2545-a946-e053-6294a90a05d22025-01-09Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC95757436-2093-41cf-a9a9-ef2f28ac096f2025-01-09Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.2b395a14-0f8e-7f5b-e063-6294a90ab5462025-01-08Warnings, 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
44608ORIG2008-02-01
4650SUPPL2004-06-10
21515ORIG2004-05-06
27084ORIG2000-10-12
14644ORIG2000-10-12