Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090145
Company: NOVEL LABS INC
Company: NOVEL LABS INC
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 |
---|---|---|---|---|---|---|---|
01/25/2012 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/17/2019 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
06/13/2012 | SUPPL-1 | Labeling-Container/Carton Labels |
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 |