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 1 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
gabapentinGABAPENTINREMEDYREPACK INC.4a975ebe-ae0a-446a-8a3d-2ca325e28f932026-09-11Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINREMEDYREPACK INC.167d8b87-506c-4293-9579-563feaa715832026-09-10Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINClinical Solutions Wholesale, LLCb7f9a106-52c6-49e4-acf5-8fb07761ba4f2026-09-09Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.d35cd5ac-5ed6-2405-e053-2995a90a69462026-09-03Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINPHOENIX RX LLC5a85ea98-4211-54eb-e063-6294a90aff332026-09-02Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINREMEDYREPACK INC.1373587e-807a-462a-bff6-8a7113ce9f0a2026-09-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINREMEDYREPACK INC.78445dbf-c7cd-419f-a7be-72821e4966282026-08-28Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINREMEDYREPACK INC.4615aaa7-73d4-4473-8f26-e7a982f8a1662026-08-27Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack1af098ad-28b5-463f-8efa-24d70a77d64c2026-08-26Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack9a2658d5-9b0e-4921-b4c5-4c89f1630d692026-08-26Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack43cbff48-8219-41ba-b67d-3ae4544b78bb2026-08-26Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINBryant Ranch Prepack4c22c3e6-2471-4b89-945b-f846c4d7884e2026-08-25Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINREMEDYREPACK INC.d06380d0-c894-427e-b13e-5a8f9eb86a342026-08-21Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINREMEDYREPACK INC.7652adc6-1aad-4422-b85c-0c6b11c23b732026-08-21Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepackf0e7a6c9-ae6c-4259-81ab-a37db54e3c802026-08-19Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
gabapentinGABAPENTINNuCare Pharmaceuticals, Inc.596eb696-7696-202e-e063-6394a90a28442026-08-19Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepackeb2f6784-e7be-41b6-871b-2c3c961664ab2026-08-19Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack8a781649-3271-47a6-995f-50f91141a48a2026-08-19Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack6670a64f-7f58-479f-b285-394abb753e2e2026-08-19Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINCoupler LLC5954a330-c225-00bd-e063-6294a90a75812026-08-18Warnings, 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