Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 076652
Company: LANNETT CO INC
Company: LANNETT CO INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GLYCOLAX | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | 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 |
|---|---|---|---|---|---|---|---|
| 07/02/2004 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076652_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/16/2005 | SUPPL-2 | Labeling |
Label is not available on this site. |
GLYCOLAX
FOR SOLUTION;ORAL; 17GM/SCOOPFUL
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GLYCOLAX | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION;ORAL | Prescription | No | AA | 076652 | LANNETT CO INC |
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION;ORAL | Prescription | No | AA | 077706 | NEXGEN PHARMA INC |
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION;ORAL | Prescription | No | AA | 077893 | PADDOCK LLC |
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