FDA.reportPublic FDA data

Application 020698

Type
NDA
Sponsor
BRAINTREE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIRALAXPOLYETHYLENE GLYCOL 3350FOR SOLUTION; ORAL17GM/SCOOPFULNoNo

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 5 of 5 · 93 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
laxativePOLYETHYLENE GLYCOL 3350Rite Aid Corporation3ebe9191-8e0a-41cf-b759-82ecce4f50e42023-02-10WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
dg health clearlaxPOLYETHYLENE GLYCOL 3350Dolgencorp, LLC94280ce4-b2cf-451d-a660-b26ab1a2d3f02023-02-06WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
clearlaxPOLYETHYLENE GLYCOL 3350H E B0b4b752d-045d-4ff0-8e50-5607d1a841a72023-01-26WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
Good Sense Clear LaxPOLYETHYLENE GLYCOL 3350L. Perrigo Company435db89c-1e32-4da5-b7d0-15e4071627152023-01-24WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
basic care clearlaxPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC21897170-0d5e-4326-bebf-10258e0aca822022-12-08WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350Geri-Care Pharmaceutical Corpf4c7eb80-d8d5-406d-90d0-9d17914d71f22022-11-24WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Gericare Pharmaceuticals5d0d2c14-24e6-45b4-92f6-4eaf5da72cdd2022-10-28WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
Equate ClearLAXPOLYETHYLENE GLYCOL 3350WALMART INC.c5c13378-3c08-415f-8ab4-8a18d6300ca82022-09-08WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
injoy constipation reliefPOLYETHYLENE GLYCOL 3350L. Perrigo Companyb2414517-04bf-4f29-951e-b867855078c32022-08-19WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
Good Sense Clear LaxPOLYETHYLENE GLYCOL 3350Proficient Rx LP0858a914-4812-4e4d-82f8-ecf93d43ef3b2022-07-01WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
GAVILAXPOLYETHYLENE GLYCOL 3350Proficient Rx LP199d6173-3fad-49e4-88fe-bde7223ed4c32022-06-01WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
signature care clearlaxPOLYETHYLENE GLYCOL 3350Safeway91d2e780-2aae-411c-b7b3-820302f0f63e2021-05-13WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 3350 NFPOLYETHYLENE GLYCOL 3350SUNRISE PHARMACEUTICAL, INCce5197a1-2677-4ffb-aef2-9221b28ebd232020-01-22WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
25533SUPPL2004-08-10
25532SUPPL2004-06-09
20831ORIG1999-08-17
35152ORIG1999-02-18
25531ORIG1999-02-18