Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202850
Company: ANI PHARMS
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION;ORAL | Over-the-counter | None | 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 |
---|---|---|---|---|---|---|---|
12/15/2015 | 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 |
---|---|---|---|---|---|
11/30/2021 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
POLYETHYLENE GLYCOL 3350
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
FOR SOLUTION;ORAL; 17GM/SCOOPFUL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
MIRALAX | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION;ORAL | Over-the-counter | Yes | 022015 | BAYER HEALTHCARE LLC |
POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION;ORAL | Over-the-counter | No | 202850 | ANI PHARMS |
POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION;ORAL | Over-the-counter | No | 214990 | ANNORA PHARMA |
POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION;ORAL | Over-the-counter | No | 209017 | AUROBINDO PHARMA LTD |
POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION;ORAL | Over-the-counter | No | 202071 | ELYSIUM |
POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION;ORAL | Over-the-counter | No | 090812 | LGM PHARMA |
POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION;ORAL | Over-the-counter | No | 078915 | MYLAN |
POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION;ORAL | Over-the-counter | No | 091077 | NOVEL LABS INC |
POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION;ORAL | Over-the-counter | No | 206105 | NUVO PHARMS INC |
POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION;ORAL | Over-the-counter | No | 090685 | PPI-DAC |
POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION;ORAL | Over-the-counter | No | 079214 | STRIDES PHARMA |
POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION;ORAL | Over-the-counter | No | 203928 | STRIDES PHARMA |