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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213135
Company: BRAINTREE LABS

Medication Guide

Products on NDA 213135

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUTAB	MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE	0.225GM;0.188GM;1.479GM	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213135

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/10/2020	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213135s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213135Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213135Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/24/2023	SUPPL-4	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213135Orig1s004correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213135Orig1s004ltr.pdf
01/28/2022	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213135s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213135Orig1s003ltr.pdf

Labels for NDA 213135

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/24/2023	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213135Orig1s004correctedlbl.pdf
10/24/2023	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213135Orig1s004correctedlbl.pdf
01/28/2022	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213135s003lbl.pdf
01/28/2022	SUPPL-3	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213135s003lbl.pdf
11/10/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213135s000lbl.pdf

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