Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019357
Company: QOL MEDCL
Company: QOL MEDCL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ETHAMOLIN | ETHANOLAMINE OLEATE | 50MG/ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/22/1988 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/05/2013 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/2014 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/20/2002 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/2002 | SUPPL-14 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19357s14ltr.pdf |
| 04/20/2001 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/16/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/16/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/03/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/01/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/29/1993 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 09/15/1992 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/29/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/26/1992 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/03/1992 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/10/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/18/1991 | SUPPL-1 | Labeling |
Label is not available on this site. |