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 15 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GABAPENTINGABAPENTINBryant Ranch Prepack1fd95278-842f-4bf9-abd5-4d9aa858d36d2024-12-10Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINBryant Ranch Prepack97a1d45d-d5b3-4be7-9b3a-cb6f80f602912024-12-09Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LP481e6b68-50e4-4594-9815-32580a84ab8c2024-12-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINZydus Lifesciences Limitedb033c169-4943-4ad9-ace0-7e4a1f0dc1002024-11-30Name fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINAsclemed USA, Inc.17a62334-209d-4dc1-867a-e5780196a2ca2024-11-05Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.a072d5d2-8c75-59cc-e053-2a95a90ac0cc2024-11-05Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack7b404ab9-8a7e-49d4-920f-487875d14e452024-11-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINBryant Ranch Prepackc33c4d83-cc13-4104-9e24-d4cd40b17b702024-10-31Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINBryant Ranch Prepacke2d9bd8c-3bb9-4945-8e61-7d2703d9008c2024-10-31Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINBryant Ranch Prepack5769d849-4f27-4701-97ec-7e3ca07339d72024-10-31Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINWestminster Pharmaceuticals, LLC2f70c496-b58c-30f5-e054-00144ff8d46c2024-10-31Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINBryant Ranch Prepack78088f6a-06a3-422f-b336-4a57a24adc162024-10-30Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack657349fb-41a9-4814-b4ac-4c5afbdde9472024-10-30Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepacka15d5dcc-63c4-4c06-ab91-5e22cdf234cc2024-10-30Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack477691f5-0591-4544-840a-ac590e1f25a12024-10-30Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack506bf880-9564-404c-951a-703797ffdad82024-10-29Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack77754734-4125-42b1-97c8-458bcab2bcf12024-10-23Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepackfb0b6613-57d6-4e24-946f-f5f87c460cf02024-10-18Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepackef37f2a0-3b83-4f71-91c0-6435161b483c2024-10-18Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepackff28c5f1-da56-4072-a6fa-d689d4a6761b2024-10-07Warnings, 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