Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202511
Company: NOVEL LABS INC
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
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)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202511Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202511Orig1s000ltr.pdf
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

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
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
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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