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 9 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GABAPENTINGABAPENTINCamber Pharmaceuticals, Inc.b86c81d9-9a4a-4847-be18-520e5cc5dc4b2025-12-12Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINJVET PHARMACEUTICALS LLC63a5fc6d-ca57-4726-b70d-805ac023d9592025-12-10Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINGlenmark Pharmaceuticals Inc., USA3865a6e3-112c-490c-82ac-35401336b16e2025-12-05Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINPrecision Dose, Inc.021329d0-7d32-4fd8-81bf-a8b0d8b49e432025-12-04Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINRedpharm Drug44f2b497-55b2-864f-e063-6294a90ad6d52025-12-02Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINKesin Pharma Corporation4470a567-93a6-a293-e063-6394a90affc12025-11-25Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINA-S Medication Solutionsb74a427c-9cc1-4b15-9ed2-cc891741fe672025-11-19Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINStrides Pharma Science Limitedbec31452-b52b-4698-ba4c-0b614780ee842025-11-12Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAcella Pharmaceuticals, LLC3255245c-6ae6-46ab-a1c1-0b8d4d4cdaa22025-11-03Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack5134369d-c7f6-4569-a425-d50e5a5d694f2025-10-29Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINMullan Pharmaceutical Inc.47a22de2-ec66-45be-8648-89ed3ab6e67e2025-10-28Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINA-S Medication Solutions25befbfa-5125-4363-8306-f862e81c0a6f2025-10-28Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepackd9d78138-e1e9-4107-9099-4910cb1422d82025-10-22Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINA-S Medication Solutions6e900fc4-a2b3-411f-9ab7-8dcbb97b697b2025-10-16Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINA-S Medication Solutionsaa246838-609c-4254-a8ec-d6f463a179602025-10-16Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepackefb86e22-5a84-4b33-aad0-71dd5a2c6c8f2025-10-13Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINA-S Medication Solutions1ead7343-ab25-41b5-af4f-f903470e1dd92025-10-10Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINA-S Medication Solutions781b0d62-a760-4371-8908-1f61329928a62025-10-10Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINSTALLION LABORATORIES PRIVATE LIMITEDb26fd0c6-6aab-4957-8a32-cc7adb9b5fc92025-10-03Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAmerican Health Packagingbbfdedd7-2baf-4bc6-be59-548a5cf217522025-10-03Warnings, 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