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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202511
Company: NOVEL LABS INC

Products on ANDA 202511

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
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	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202511

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/23/2017	ORIG-1	Approval			Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202511Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202511Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/202511orig1s000.pdf

Labels for ANDA 202511

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/23/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202511Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 202511

SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM 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

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