Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206431
Company: TARO

Products on ANDA 206431

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE	MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206431

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/19/2024	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206431Orig1s000TALtr.pdf

Therapeutic Equivalents for ANDA 206431

MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

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