FDA.reportPublic FDA data

Application 204558

Type
ANDA
Sponsor
STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POLYETHYLENE GLYCOL 3350 AND ELECTROLYTESPOLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUSFOR SOLUTION;ORAL236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204558-001POLYETHYLENE GLYCOL 3350 AND ELECTROLYTESPOLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2018-12-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A204558-001AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A204558-001POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2018-12-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204558-001AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Polyethylene Glycol 3350 and electrolytes - UnflavoredPOLYETHYLENE GLYCOL 3350 AND ELECTROLYTES - UNFLAVOREDStrides Pharma Science Limited48c741a9-9039-4fdb-a875-86d4ea9682822025-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204558
application number: ANDA204558
ndc (product): 64380-765
ndc (product): 64380-767
ndc (product): 64380-766

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64380-765Polyethylene Glycol 3350 and electrolytes - UnflavoredPolyethylene Glycol 3350 and electrolytes - UnflavoredStrides Pharma Science LimitedANDACurrent
64380-765Polyethylene Glycol 3350 and electrolytes - UnflavoredPolyethylene Glycol 3350 and electrolytes - UnflavoredStrides Pharma Science LimitedANDACurrent
64380-765Polyethylene Glycol 3350 and electrolytes - UnflavoredPolyethylene Glycol 3350 and electrolytes - UnflavoredStrides Pharma Science LimitedANDACurrent
64380-765Polyethylene Glycol 3350 and electrolytes - UnflavoredPolyethylene Glycol 3350 and electrolytes - UnflavoredStrides Pharma Science LimitedANDACurrent
64380-765Polyethylene Glycol 3350 and electrolytes - UnflavoredPolyethylene Glycol 3350 and electrolytes - UnflavoredStrides Pharma Science LimitedANDACurrent
64380-766Polyethylene Glycol 3350 and electrolytes with Lemon FlavorPolyethylene Glycol 3350 and electrolytes with Lemon FlavorStrides Pharma Science LimitedANDACurrent
64380-766Polyethylene Glycol 3350 and electrolytes with Lemon FlavorPolyethylene Glycol 3350 and electrolytes with Lemon FlavorStrides Pharma Science LimitedANDACurrent
64380-766Polyethylene Glycol 3350 and electrolytes with Lemon FlavorPolyethylene Glycol 3350 and electrolytes with Lemon FlavorStrides Pharma Science LimitedANDACurrent
64380-766Polyethylene Glycol 3350 and electrolytes with Lemon FlavorPolyethylene Glycol 3350 and electrolytes with Lemon FlavorStrides Pharma Science LimitedANDACurrent
64380-766Polyethylene Glycol 3350 and electrolytes with Lemon FlavorPolyethylene Glycol 3350 and electrolytes with Lemon FlavorStrides Pharma Science LimitedANDACurrent
64380-767Polyethylene Glycol 3350 and electrolyteswith Orange FlavorPolyethylene Glycol 3350 and electrolytes with Orange FlavorStrides Pharma Science LimitedANDACurrent
64380-767Polyethylene Glycol 3350 and electrolyteswith Orange FlavorPolyethylene Glycol 3350 and electrolytes with Orange FlavorStrides Pharma Science LimitedANDACurrent
64380-767Polyethylene Glycol 3350 and electrolyteswith Orange FlavorPolyethylene Glycol 3350 and electrolytes with Orange FlavorStrides Pharma Science LimitedANDACurrent
64380-767Polyethylene Glycol 3350 and electrolyteswith Orange FlavorPolyethylene Glycol 3350 and electrolytes with Orange FlavorStrides Pharma Science LimitedANDACurrent
64380-767Polyethylene Glycol 3350 and electrolyteswith Orange FlavorPolyethylene Glycol 3350 and electrolytes with Orange FlavorStrides Pharma Science LimitedANDACurrent