FDA.reportPublic FDA data

Application 202998

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREGABALINPREGABALINSOLUTION;ORAL20MG/MLNoNo

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 12 · 226 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINREMEDYREPACK INC.ab06a36d-9a2d-4eae-8991-4eab5bc8311c2026-09-11Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINClinical Solutions Wholesale, LLC93c2fe8b-67d7-4a15-8790-5595e158b3ab2026-09-09Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.e897d7e8-2743-4512-8417-375cb11ceec62026-09-03Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.84bf3abb-559d-4140-a689-f3e26b1c4ff22026-09-02Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy923745e9-17a2-a5f7-e053-2a95a90aed382026-09-01Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINPreferred Pharmaceuticals Inc.7f29991e-3bf5-4e48-8fa3-6d4e932ed6de2026-08-21Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINPreferred Pharmaceuticals, Inc.ce1419bc-c348-4407-b320-e0598d5a7b192026-08-21Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.d095accf-9cea-4948-b43d-ae1b8fbce7c22026-08-20Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.12309847-0857-4ff7-a7e7-edeadc3dfb612026-08-14Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.47d08b8f-a24d-4159-ab43-2eb67a93559b2026-08-14Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.3c8ea6da-5771-4096-a915-700e51ced05c2026-08-14Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.9c38abbc-2b3d-48d6-b629-4a163c803db52026-08-14Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.efe06a26-30c5-437d-9fd1-4bd0062f12002026-08-14Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.f30a7a3b-d45e-4e0b-ab1b-1369b2f023202026-08-06Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.326c643a-23c5-4dab-9266-abc22ca1f8742026-08-06Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.5d738807-7f88-4943-9c3b-01f1e52ea72d2026-08-05Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINAscend Laboratories, LLCe48db3c2-7351-41f2-a451-5a8341c4125c2026-08-04Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.9685792b-911d-4cf9-9881-d21abca48c662026-08-03Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.c60752f8-20d5-4333-bf33-a656eab01d6b2026-08-03Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.0f72ec70-314c-4c9f-86be-54f3e010356d2026-08-03Warnings, Adverse reactionsName fallback
brand name: Pregabalin
generic name: PREGABALIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.