Application 204553

Type: NDA
Sponsor: GATOR PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	COLPREP KIT	MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE	POWDER;ORAL	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N204553-001	COLPREP KIT	MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	POWDER / ORAL		RLD	2016-12-27

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N204553-001	COLPREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	POWDER / ORAL	RLD	2016-12-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204553-001	COLPREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	POWDER / ORAL	RLD	2016-12-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N204553-001	COLPREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	POWDER / ORAL	RLD	2016-12-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204553-001	COLPREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	POWDER / ORAL	RLD	2016-12-27	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10702-283	ColPrep Kit	sodium sulfate, potassium sulfate, and magnesium sulfate for oral solution	KVK-Tech, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
50466	ORIG	2017-11-21
46587	ORIG	2016-12-29
46578	ORIG	2016-12-29