Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204154
Company: EDENBRIDGE PHARMS
Company: EDENBRIDGE PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IVERMECTIN | IVERMECTIN | 3MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 10/24/2014 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204154Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204154Orig1s000ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/24/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204154Orig1s000lbl.pdf |
IVERMECTIN
TABLET;ORAL; 3MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| IVERMECTIN | IVERMECTIN | 3MG | TABLET;ORAL | Prescription | No | AB | 204154 | EDENBRIDGE PHARMS |
| STROMECTOL | IVERMECTIN | 3MG | TABLET;ORAL | Prescription | Yes | AB | 050742 | MERCK SHARP DOHME |
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