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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207498
Company: TARO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE 4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM FOR 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
06/28/2024 ORIG-1 Approval STANDARD

Label is not available on this site.

PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID

FOR SOLUTION;ORAL; 4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MOVIPREP ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE 4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM FOR SOLUTION;ORAL Prescription Yes AA 021881 SALIX PHARMS
PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE 4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM FOR SOLUTION;ORAL Prescription No AA 090145 NOVEL LABS INC
PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE 4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM FOR SOLUTION;ORAL Prescription No AA 207498 TARO
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