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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022372
Company: BRAINTREE LABS

Medication Guide

Summary Review

Products on NDA 022372

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUPREP BOWEL PREP KIT	MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION;ORAL	Prescription	AA	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022372

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/05/2010	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022372s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022372s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022372_suprep_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022372Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/05/2020	SUPPL-13	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022372Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022372Orig1s013ltr.pdf
07/24/2012	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
11/06/2012	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022372s004lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022372Orig1s004ltr.pdf
07/06/2011	SUPPL-3	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022372s003ltr.pdf

Labels for NDA 022372

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/05/2020	SUPPL-13	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022372Orig1s013lbl.pdf
11/06/2012	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022372s004lbledt.pdf
11/06/2012	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022372s004lbledt.pdf
08/05/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022372s000lbl.pdf

Therapeutic Equivalents for NDA 022372

SUPREP BOWEL PREP KIT

SOLUTION;ORAL; 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE	MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION;ORAL	Prescription	No	AA	206431	TARO
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE	MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION;ORAL	Prescription	No	AA	213924	ALKEM LABS LTD
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE	MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION;ORAL	Prescription	No	AA	202511	NOVEL LABS INC
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE	MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION;ORAL	Prescription	No	AA	215469	STRIDES PHARMA
SUPREP BOWEL PREP KIT	MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION;ORAL	Prescription	Yes	AA	022372	BRAINTREE LABS

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