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 6 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINSt Mary's Medical Park Pharmacyde990f96-96bc-406d-e053-2995a90abebb2026-05-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack4cb26d6e-7963-4fe5-903e-ab51805450662026-05-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINPreferred Pharmaceuticals Inc.100ff86c-56a8-4770-9db3-b9bc6b1bd2f72026-04-30Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINPD-Rx Pharmaceuticals, Inc.d22ed424-f365-44ca-8ef9-a08255a90ae82026-04-29Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINPreferred Pharmaceuticals Inc.e3429322-c442-4146-bb68-bcc3a8d015522026-04-29Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINPreferred Pharmaceuticals Inc.2625c0ef-5295-41de-9e81-88001a6cbecc2026-04-29Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINPreferred Pharmaceuticals Inc.6ecf5114-2ddc-4025-a36d-1884702dc22a2026-04-29Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINPreferred Pharmaceuticals Inc.f396ec70-826d-45c6-a27c-343c2fac878c2026-04-29Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINPreferred Pharmaceuticals, Inc.41dcc917-68d1-49f0-8223-44c21ca259ef2026-04-29Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINCoupler LLC5073abda-321f-29d1-e063-6394a90a59ac2026-04-27Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBluePoint Laboratories3368bf70-d466-4765-b2b7-7fe967a8c2b72026-04-24Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINCoupler LLC500ee820-0378-6fc9-e063-6394a90a109c2026-04-24Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.dd0e12c2-1986-4ca3-a809-d703a75424192026-04-22Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINPHOENIX RX LLC4f95c01f-200e-bfd7-e063-6394a90abc382026-04-16Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepackce0f0d7f-da6d-47da-a4ed-fb8f729024122026-04-13Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepackabb56036-88df-4720-ba78-5299716715452026-04-13Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepacka75c9157-a1fc-44cc-89f8-c5a3742fb9ed2026-04-13Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepackd1aa4690-57b5-4a3e-ac12-85f777dbd05e2026-04-13Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
RELGAABIGABAPENTINMethod Pharmaceuticals, LLC4cc6615b-5447-9c0e-e063-6394a90a28832026-04-08Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack632cb507-5675-2392-0460-b09c0dd146502026-04-07Warnings, 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